FDA Product Code
FDA Product Code CJO — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Clinical Chemistry
- 21 CFR Citation
- 862.1050
510(k) Clearances — 4 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K122323 | DIMENSION VISTA ALKALINE PHOSPHATASE (ALPI) FLEX REAGENT CARTRIDGE DIMENSION VISTA ALKALINE PHOSPHATASE CALIBRATOR (ALPI | Siemens Healthcare Diagnostics | 2012-08-28 | Traditional | PDF ↗ |
| K121907 | DIMENSION ALKALINE PHOSPHATASE FLEX REAGENT CARTRIDGE, DIMENSION ALKALINE PHOSPHATASE CALIBRATOR | Siemens Healthcare Diagnostics | 2012-07-23 | Traditional | PDF ↗ |
| K982328 | BAYER ADVIA IMS SYSTEM (IN VITRO DIAGNOSTIC SYSTEM) | Bayer Corp. | 1999-01-29 | Traditional | PDF ↗ |
| K770155 | ALKALINE PHOSPHATASE ISOYZME REAGENT SET | Gelman Instrument Co. | 1977-01-31 | Traditional | PDF ↗ |
Product code CJO · Class II · Clinical Chemistry. Data: openFDA.