CIW
8 FDA 510(k) clearances · Product code
70 daysmedian time to decision
212 days90th percentile
8clearances measured
FDA profile
- Official device name
- Starch-Dye Bound Polymer, Amylase
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1070
- Medical specialty
- Clinical Chemistry
- Flags
- Third-party review eligible
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| DMA AMYLASE PROCEDURE (K931559) | Data Medical Associates, Inc. | 1993-10-28 |
| OLYMPUS AMYLASE REAGENT (K924339) | Olympus Corp. | 1992-10-19 |
| AMYLASE TEST (AMYL) ITEM NUMBER: 65653 (K884382) | Em Diagnostic Systems, Inc. | 1989-01-11 |
| ENZYMATIC ALPHA-AMYLASE REAGENT KIT (K850639) | Bio-Analytics Laboratories, Inc. | 1985-03-05 |
| KODAK EKTACHEM CLIN. CHEM. SLIDES (AMYL) (K812027) | Eastman Kodak Company | 1981-08-03 |
| PHADEBAS ISOAMYLASE TEST (K810584) | Pharmacia, Inc. | 1981-05-13 |
| PANTRAK E.K. (K810669) | Calbiochem-Behring Corp. | 1981-03-31 |
| UNITEST AMYLASE (K782032) | Boehringer Mannheim Corp. | 1979-03-02 |
Track CIW automatically
Every clearance here is in the API, with alerts when new ones post.