FDA Product Code
FDA Product Code CIW — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Clinical Chemistry
- 21 CFR Citation
- 862.1070
510(k) Clearances — 8 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K931559 | DMA AMYLASE PROCEDURE | Data Medical Associates, Inc. | 1993-10-28 | Traditional | PDF ↗ |
| K924339 | OLYMPUS AMYLASE REAGENT | Olympus Corp. | 1992-10-19 | Traditional | PDF ↗ |
| K884382 | AMYLASE TEST (AMYL) ITEM NUMBER: 65653 | Em Diagnostic Systems, Inc. | 1989-01-11 | Traditional | PDF ↗ |
| K850639 | ENZYMATIC ALPHA-AMYLASE REAGENT KIT | Bio-Analytics Laboratories, Inc. | 1985-03-05 | Traditional | PDF ↗ |
| K812027 | KODAK EKTACHEM CLIN. CHEM. SLIDES (AMYL) | Eastman Kodak Company | 1981-08-03 | Traditional | PDF ↗ |
| K810584 | PHADEBAS ISOAMYLASE TEST | Pharmacia, Inc. | 1981-05-13 | Traditional | PDF ↗ |
| K810669 | PANTRAK E.K. | Calbiochem-Behring Corp. | 1981-03-31 | Traditional | PDF ↗ |
| K782032 | UNITEST AMYLASE | Boehringer Mannheim Corp. | 1979-03-02 | Traditional | PDF ↗ |
Product code CIW · Class II · Clinical Chemistry. Data: openFDA.