Synchron
SYNCHRON Control Multilevel Comprehensive Chemistry Control Serum
1manufacturer
6catalogue numbers in this listing
6510(k) clearances naming this product code
1recall
Who Else Makes It
Registered in Jiangsu.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Getein Biotech, Inc. | Nanjing | Jiangsu | Manufacturer | 19 |
Record
| Listed by | Beckman Coulter, Inc., United States |
|---|---|
| FDA product code | JJY |
| Device type | Multi-Analyte Controls, All Kinds (Assayed) |
| Device class | Class 1 |
| Regulation | 21 CFR 862.1660 |
| Establishment | Contract manufacturer, Specification developer, Manufacturer, Exporter |
| 510(k) | K993023 |
| Record published | 2016-08-24 |
| Record revised | 2023-08-28 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 465914 | In distribution | |
| 657365 | In distribution | |
| 465939 | In distribution | |
| 474988 | In distribution | |
| 474991 | In distribution | |
| 465912 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Liquichek | Bio-Rad Laboratories Inc. | 154 |
| Validate | LGC Clinical Diagnostics, Inc. | 120 |
| InteliQ | Bio-Rad Laboratories Inc. | 50 |
| Lyphochek | Bio-Rad Laboratories Inc. | 39 |
| Stat Profile | Nova Biomedical Corporation | 38 |
| i-STAT | Abbott Point OF Care Inc. | 24 |
| Multichem AE | Techno-Path Manufacturing Ltd. | 20 |
| Serum Control | Chromsystems Instruments & Chemicals Gmbh | 18 |
| BioPlex 2200 | Bio-Rad Laboratories Inc. | 16 |
| Nova | Nova Biomedical Corporation | 14 |
| Plasma Control | Chromsystems Instruments & Chemicals Gmbh | 14 |
| Multichem IA Speciality | Techno-Path Manufacturing Ltd. | 12 |
Showing 12 of 559. All products under Multi-Analyte Controls, All Kinds (Assayed)
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K020521 | 2002-03-01 |
| K013235 | 2001-10-16 |
| K010358 | 2001-03-05 |
| K003488 | 2000-11-27 |
| K993023 | 1999-11-26 |
| K982224 | 1998-07-09 |
Recalls
The FDA has not published a severity grade for these. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Closed |
|---|---|---|---|---|
| 2004-07-30 | Not classified | Other | Results of tests are biased low due to a vendor change in formulation not brought to the attention of the recalling firm. | 2004-08-30 |
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.