Phoenix Diagnostics, Inc.
ISE Cal Pack (Snap Pack) for Medica Na/K/Ca/pH EasyLyte Electrolyte Systems
3manufacturers in China registered for this device type
15catalogue 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) | K013451 |
| Record published | 2018-01-25 |
| Record revised | 2020-03-30 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment temperature 15 to 30 °C |
| Packaging | Pack of 10, pack of 4, pack of 30, case of 4 |
| Sizes | Total volume 60 ml |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 13-011 | In distribution | |
| 19-007D | In distribution | |
| 19-005 | In distribution | |
| 23-202 | In distribution | |
| PH7000 | In distribution | |
| PH7001 | In distribution | |
| 21-106 | In distribution | |
| 19-006IL | In distribution | |
| 3-701 | In distribution | |
| 3-702 | In distribution | |
| 13-002 | In distribution | |
| 16-215 | In distribution | |
| 13-020 | In distribution | |
| 19-006 | In distribution | |
| 13-005 | Total Volume 60 ml | 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 |
| Phoenix Diagnostics | Phoenix Diagnostics, Inc. | 20 |
| Nova | Nova Biomedical Corporation | 15 |
| Plasma Calibration Standard | Chromsystems Instruments & Chemicals Gmbh | 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.