Elecsys Vitamin D CalCheck 5
Catalogue number 6416632160, listed by Roche Diagnostics Gmbh, Germany, under Single (Specified) Analyte Controls (Assayed And Unassayed). 12 manufacturers in China are registered for this product code.
12manufacturers in China registered for this device type
1catalogue number
60510(k) clearances naming this product code
Who Else Makes It
Concentrated in Zhejiang (3), Guangdong (3), Jilin (1). 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Acon Biotech (Hangzhou) Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 29 |
| Flextronics Industrial (Shenzhen) Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 5 |
| Yasee Biomedical Inc | Qingdao | Shandong | Contract manufacturer | 5 |
| Dirui Industrial Co., Ltd. | Changchun | Jilin | Contract manufacturer | 84 |
| Vivachek Biotech (Hangzhou) Co., Ltd. | Hangzhou, Zhuji | Zhejiang | Contract manufacturer | 21 |
| Guangdong Transtek Medical Electronics Co., Ltd. | Zhongshan | Guangdong | Contract manufacturer | 11 |
| Tianjin Empecs Medical Device Co., Ltd. | Tianjin | Tianjin | Contract manufacturer | 8 |
| BD Rapid Diagnostics (Suzhou) Co., Ltd. | China (Jiangsu) Pilot Free Trade Zone Suzhou Area | Manufacturer | 6 | |
| Sejoy Biomedical Co., Ltd. | Hangzhou | Zhejiang | Manufacturer | 5 |
| Beijing Genesee Biotech, Inc. | Beijing | Beijing | Manufacturer | 4 |
| Human Metabolomics Institute, Inc. | Shenzhen | Guangdong | Manufacturer | 4 |
| Changsha Sinocare Inc. | Changsha | Hunan | Manufacturer | 2 |
Record
| Listed by | Roche Diagnostics Gmbh, Germany |
|---|---|
| FDA product code | JJX |
| Device type | Single (Specified) Analyte Controls (Assayed And Unassayed) |
| Device class | Class 1 |
| Regulation | 21 CFR 862.1660 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2021-01-18 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 6416632160 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Vitros | Ortho-Clinical Diagnostics, Inc. | 55 |
| Validate | LGC Clinical Diagnostics, Inc. | 37 |
| Architect | Abbott Laboratories | 24 |
| Architect | Abbott Medical | 23 |
| BioPlex 2200 | Bio-Rad Laboratories Inc. | 22 |
| Architect | Abbott Ireland | 18 |
| Liquichek | Bio-Rad Laboratories Inc. | 17 |
| Alinity | Abbott Medical | 17 |
| Alinity | Abbott Ireland | 15 |
| Fora | Fora Care Inc. | 15 |
| Pregnancy-Skreen | Biochemical Diagnostics, Inc. | 14 |
| Accurun® | LGC Clinical Diagnostics, Inc. | 14 |
Showing 12 of 907. All products under Single (Specified) Analyte Controls (Assayed And Unassayed)
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K170678 | 2017-04-04 |
| K162173 | 2017-01-12 |
| K150955 | 2015-05-01 |
| K143284 | 2014-12-16 |
| K142127 | 2014-09-05 |
| K140534 | 2014-03-27 |
| K133284 | 2013-11-22 |
| K122242 | 2012-12-05 |
| K121895 | 2012-08-24 |
| K121279 | 2012-05-10 |
| K112528 | 2011-10-18 |
| K112113 | 2011-09-14 |
| K112104 | 2011-08-25 |
| K111552 | 2011-07-21 |
| K111349 | 2011-06-09 |
| K110613 | 2011-05-12 |
| K103402 | 2011-01-07 |
| K103099 | 2010-12-06 |
| K103162 | 2010-11-18 |
| K102086 | 2010-11-01 |
| K102269 | 2010-10-07 |
| K101365 | 2010-10-05 |
| K101856 | 2010-10-05 |
| K102267 | 2010-09-10 |
| K102044 | 2010-08-31 |
| K101075 | 2010-06-11 |
| K094031 | 2010-04-27 |
| K100810 | 2010-04-26 |
| K093836 | 2010-04-15 |
| K100594 | 2010-04-01 |
| K093582 | 2010-03-29 |
| K092848 | 2010-03-19 |
| K093700 | 2010-03-04 |
| K092169 | 2009-12-16 |
| K092168 | 2009-11-16 |
| K092888 | 2009-11-10 |
| K092585 | 2009-10-30 |
| K091601 | 2009-09-25 |
| K090311 | 2009-05-05 |
| K083655 | 2009-02-12 |
| K080643 | 2008-08-22 |
| K080147 | 2008-02-27 |
| K062972 | 2006-10-13 |
| K053059 | 2005-11-28 |
| K043320 | 2004-12-17 |
| K040157 | 2004-02-25 |
| K031990 | 2003-08-20 |
| K031698 | 2003-08-20 |
| K020883 | 2002-11-29 |
| K020369 | 2002-03-06 |
| K010237 | 2001-02-14 |
| K003967 | 2001-01-12 |
| K003772 | 2000-12-20 |
| K001846 | 2000-06-28 |
| K001014 | 2000-06-01 |
| K001015 | 2000-04-27 |
| K000042 | 2000-03-17 |
| K993642 | 1999-11-30 |
| K981281 | 1998-04-24 |
| K981278 | 1998-04-23 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.