CJA
10 FDA 510(k) clearances · Product code
61 daysmedian time to decision
107 days90th percentile
10clearances measured
FDA profile
- Official device name
- Amyloclastic, 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 |
|---|---|---|
| MODIFIED HI CHEM AMYLASE REAGENT (PRODUCT #88129) (K895555) | Hichem Diagnostics | 1989-12-22 |
| AMYLASE REAGENT KIT FOR ASTRA SYSTEMS (K884226) | A-Kem, Inc. | 1988-12-09 |
| WAKO(TM) AUTOKIT AMYLASE (K883059) | Wako Chemicals USA, Inc. | 1988-08-30 |
| PARAMAX AMYLASE REAGENT (K873520) | Baxter Healthcare Corp | 1987-11-23 |
| ALPHA AMYLASE (K863052) | J. D. Assoc. | 1986-09-09 |
| AMYLASE LTS (K862640) | Electro-Nucleonics Laboratories, Inc. | 1986-09-09 |
| AMYLASE REAGENT SET (MODIFIED CARAWAY) (K860530) | Sterling Diagnostics, Inc. | 1986-02-28 |
| AMYLASE REAGENT CS-726 (K844168) | Fisher Scientific Co., LLC | 1984-11-20 |
| ASTRA SYSTEMS AMYLASE REAGENT KIT (K843529) | Beckman Instruments, Inc. | 1984-10-11 |
| AMYLASE REAGENT SET-MODIFIED CARAWAY (K833864) | Sterling Biochemical, Inc. | 1984-01-13 |
Track CJA automatically
Every clearance here is in the API, with alerts when new ones post.