CIW · Starch-Dye Bound Polymer, Amylase
Clinical Chemistry · 21 CFR 862.1070 · Class 2
Overview
| Product Code | CIW |
|---|---|
| Device Name | Starch-Dye Bound Polymer, Amylase |
| Regulation | 21 CFR 862.1070 |
| Device Class | Class 2 |
| Review Panel | Clinical Chemistry |
| 3rd-Party Reviewable | Yes |
Identification
An amylase test system is a device intended to measure the activity of the enzyme amylase in serum and urine. Amylase measurements are used primarily for the diagnosis and treatment of pancreatitis (inflammation of the pancreas).
Classification Rationale
Class II.
Cleared Devices (8)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K931559 | DMA AMYLASE PROCEDURE | Data Medical Associates, Inc. | Oct 28, 1993 | SESE |
| K924339 | OLYMPUS AMYLASE REAGENT | Olympus Corp. | Oct 19, 1992 | SESE |
| K884382 | AMYLASE TEST (AMYL) ITEM NUMBER: 65653 | Em Diagnostic Systems, Inc. | Jan 11, 1989 | SESE |
| K850639 | ENZYMATIC ALPHA-AMYLASE REAGENT KIT | Bio-Analytics Laboratories, Inc. | Mar 5, 1985 | SESE |
| K812027 | KODAK EKTACHEM CLIN. CHEM. SLIDES (AMYL) | Eastman Kodak Company | Aug 3, 1981 | SESE |
| K810584 | PHADEBAS ISOAMYLASE TEST | Pharmacia, Inc. | May 13, 1981 | SESE |
| K810669 | PANTRAK E.K. | Calbiochem-Behring Corp. | Mar 31, 1981 | SESE |
| K782032 | UNITEST AMYLASE | Boehringer Mannheim Corp. | Mar 2, 1979 | SESE |
Top Applicants
- Pharmacia, Inc. — 1 clearance
- Olympus Corp. — 1 clearance
- Em Diagnostic Systems, Inc. — 1 clearance
- Eastman Kodak Company — 1 clearance
- Data Medical Associates, Inc. — 1 clearance
