FDA Product Code
FDA Product Code CJA — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Clinical Chemistry
- 21 CFR Citation
- 862.1070
510(k) Clearances — 10 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K895555 | MODIFIED HI CHEM AMYLASE REAGENT (PRODUCT #88129) | Hichem Diagnostics | 1989-12-22 | Traditional | PDF ↗ |
| K884226 | AMYLASE REAGENT KIT FOR ASTRA SYSTEMS | A-Kem, Inc. | 1988-12-09 | Traditional | PDF ↗ |
| K883059 | WAKO(TM) AUTOKIT AMYLASE | Wako Chemicals USA, Inc. | 1988-08-30 | Traditional | PDF ↗ |
| K873520 | PARAMAX AMYLASE REAGENT | Baxter Healthcare Corp | 1987-11-23 | Traditional | PDF ↗ |
| K863052 | ALPHA AMYLASE | J. D. Assoc. | 1986-09-09 | Traditional | PDF ↗ |
| K862640 | AMYLASE LTS | Electro-Nucleonics Laboratories, Inc. | 1986-09-09 | Traditional | PDF ↗ |
| K860530 | AMYLASE REAGENT SET (MODIFIED CARAWAY) | Sterling Diagnostics, Inc. | 1986-02-28 | Traditional | PDF ↗ |
| K844168 | AMYLASE REAGENT CS-726 | Fisher Scientific Co., LLC | 1984-11-20 | Traditional | PDF ↗ |
| K843529 | ASTRA SYSTEMS AMYLASE REAGENT KIT | Beckman Instruments, Inc. | 1984-10-11 | Traditional | PDF ↗ |
| K833864 | AMYLASE REAGENT SET-MODIFIED CARAWAY | Sterling Biochemical, Inc. | 1984-01-13 | Traditional | PDF ↗ |
Product code CJA · Class II · Clinical Chemistry. Data: openFDA.