CJO · Alpha-Naphthyl Phosphate, Alkaline Phosphatase Or Isoenzymes
Clinical Chemistry · 21 CFR 862.1050 · Class 2
Overview
| Product Code | CJO |
|---|---|
| Device Name | Alpha-Naphthyl Phosphate, Alkaline Phosphatase Or Isoenzymes |
| Regulation | 21 CFR 862.1050 |
| Device Class | Class 2 |
| Review Panel | Clinical Chemistry |
| 3rd-Party Reviewable | Yes |
Identification
An alkaline phosphatase or isoenzymes test system is a device intended to measure alkaline phosphatase or its isoenzymes (a group of enzymes with similar biological activity) in serum or plasma. Measurements of alkaline phosphatase or its isoenzymes are used in the diagnosis and treatment of liver, bone, parathyroid, and intestinal diseases.
Classification Rationale
Class II.
Recent Cleared Devices (4 of 4)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K122323 | DIMENSION VISTA ALKALINE PHOSPHATASE (ALPI) FLEX REAGENT CARTRIDGE DIMENSION VISTA ALKALINE PHOSPHATASE CALIBRATOR (ALPI | Siemens Healthcare Diagnostics | Aug 28, 2012 | SESE |
| K121907 | DIMENSION ALKALINE PHOSPHATASE FLEX REAGENT CARTRIDGE, DIMENSION ALKALINE PHOSPHATASE CALIBRATOR | Siemens Healthcare Diagnostics | Jul 23, 2012 | SESE |
| K982328 | BAYER ADVIA IMS SYSTEM (IN VITRO DIAGNOSTIC SYSTEM) | Bayer Corp. | Jan 29, 1999 | SESE |
| K770155 | ALKALINE PHOSPHATASE ISOYZME REAGENT SET | Gelman Instrument Co. | Jan 31, 1977 | SESE |
Top Applicants
- Siemens Healthcare Diagnostics — 2 clearances
- Bayer Corp. — 1 clearance
- Gelman Instrument Co. — 1 clearance
