Panels › Clinical Chemistry › Product code CJO · Class 2
Alpha-Naphthyl Phosphate, Alkaline Phosphatase Or Isoenzymes
Regulation 862.1050
0510(k)s in 12 months (4 all time)
0recalls in 12 months (1 all time)
1recalls that name a 510(k)
Top companies in CJO
| Company | 510(k)s | Recalls |
|---|---|---|
| Siemens Healthcare Diagnostics | 2 | 1 |
| Bayer Corp. | 1 | 0 |
| Gelman Instrument Co. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Aug 28, 2012 | K122323 | DIMENSION VISTA ALKALINE PHOSPHATASE (ALPI) FLEX REAGENT CARTRIDGE DIMENSION VISTA ALKALINE PHOSPHATASE CALIBRATOR (ALPI Siemens Healthcare Diagnostics | CJO |
| Jul 23, 2012 | K121907 | DIMENSION ALKALINE PHOSPHATASE FLEX REAGENT CARTRIDGE, DIMENSION ALKALINE PHOSPHATASE CALIBRATOR Siemens Healthcare Diagnostics | CJO |
| Jan 29, 1999 | K982328 | BAYER ADVIA IMS SYSTEM (IN VITRO DIAGNOSTIC SYSTEM) Bayer Corp. | CJO |
| Jan 31, 1977 | K770155 | ALKALINE PHOSPHATASE ISOYZME REAGENT SET Gelman Instrument Co. | CJO |
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