CKF · Phenylphosphate, Alkaline Phosphatase Or Isoenzymes
Clinical Chemistry · 21 CFR 862.1050 · Class 2
Overview
| Product Code | CKF |
|---|---|
| Device Name | Phenylphosphate, 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 (2 of 2)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K072142 | S40 CLINICAL ANALYZER, S TEST ALP, S TEST AMYLASE, S TEST AST | Alfa Wassermann Diagnostic Technologies, Inc. | Jun 26, 2008 | SESE |
| K963383 | HICHEM ALP/AMP REAGENT KIT | Hichem Diagnostics | Sep 23, 1996 | SESE |
Top Applicants
- Alfa Wassermann Diagnostic Technologies, Inc. — 1 clearance
- Hichem Diagnostics — 1 clearance
