Phoenix Diagnostics
Universal Cal Pack (Snap Pack) for Menarini SpotLyte Series Electrolyte Systems
3manufacturers in China registered for this device type
20catalogue numbers in this listing
5510(k) clearances naming this product code
Who Else Makes It
Concentrated in Jilin (1), Guangdong (1), Jiangsu (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Dirui Industrial Co., Ltd. | Changchun | Jilin | Contract manufacturer | 84 |
| Edan Instruments, Inc. | Shenzhen | Guangdong | Contract manufacturer | 56 |
| Getein Biotech, Inc. | Nanjing | Jiangsu | Manufacturer | 19 |
Record
| Listed by | Phoenix Diagnostics, Inc., United States |
|---|---|
| FDA product code | JIX |
| Device type | Calibrator, Multi-Analyte Mixture |
| Device class | Class 2 |
| Regulation | 21 CFR 862.1150 |
| Establishment | Manufacturer |
| 510(k) | K023268 |
| Record published | 2017-04-25 |
| Record revised | 2020-11-18 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Storage | Storage environment temperature 15 to 30 °C; Handling environment temperature 15 to 30 °C |
| Packaging | Case of 4, case of 6, case of 10, pack of 4 |
| Sizes | Total volume 20 to 2000 ml |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 4-130 | Total Volume 620 ml | In distribution |
| 16-219 | Total Volume 30 ml | In distribution |
| 16-202 | Total Volume 2000 ml | In distribution |
| 19-007 | Total Volume 1080 ml | In distribution |
| 3-602 | Total Volume 200 ml | In distribution |
| 21-104 | Total Volume 100 ml | In distribution |
| 23-101 | Total Volume 420 ml | In distribution |
| 16-203 | Total Volume 1000 ml | In distribution |
| 21-101 | Total Volume 2000 ml | In distribution |
| 3-224 | Total Volume 460 ml | In distribution |
| 3-601 | Total Volume 460 ml | In distribution |
| 4-180 | Total Volume 620 ml | In distribution |
| 16-206 | Total Volume 20 ml | In distribution |
| 16-205 | Total Volume 20 ml | In distribution |
| 21-102 | Total Volume 2000 ml | In distribution |
| 23-102 | Total Volume 30 ml | In distribution |
| 3-223 | Total Volume 460 ml | In distribution |
| 3-221 | Total Volume 460 ml | In distribution |
| 19-007S | Total Volume 1080 ml | In distribution |
| 3-211 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Stat Profile | Nova Biomedical Corporation | 54 |
| BioPlex 2200 | Bio-Rad Laboratories Inc. | 32 |
| Plasma Calibrator Set | Chromsystems Instruments & Chemicals Gmbh | 22 |
| Nova | Nova Biomedical Corporation | 15 |
| Plasma Calibration Standard | Chromsystems Instruments & Chemicals Gmbh | 15 |
| Phoenix Diagnostics, Inc. | Phoenix Diagnostics, Inc. | 15 |
| Architect | Abbott Laboratories | 11 |
| Alinity | Abbott Medical | 10 |
| Synchron | Beckman Coulter, Inc. | 9 |
| Architect | Abbott Medical | 9 |
| Urine Calibration Standard | Chromsystems Instruments & Chemicals Gmbh | 8 |
| Serum Calibration Standard | Chromsystems Instruments & Chemicals Gmbh | 8 |
Showing 12 of 229. All products under Calibrator, Multi-Analyte Mixture
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K023268 | 2002-11-15 |
| K020129 | 2002-02-01 |
| K012987 | 2001-11-07 |
| K012509 | 2001-10-09 |
| K902675 | 1990-07-31 |
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.