CJA — Amyloclastic, Amylase Class II
FDA product code CJA covers "Amyloclastic, Amylase", a Class II medical device regulated under 21 CFR 862.1070. Submissions are reviewed by the Clinical Chemistry panel. At least 10 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- CJA
- Device Class
- Class II
- Regulation Number
- 862.1070
- Submission Type
- Review Panel
- CH
- Medical Specialty
- Clinical Chemistry
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K895555 | hichem diagnostics | MODIFIED HI CHEM AMYLASE REAGENT (PRODUCT #88129) | December 22, 1989 |
| K884226 | a-kem | AMYLASE REAGENT KIT FOR ASTRA SYSTEMS | December 9, 1988 |
| K883059 | wako chemicals usa | WAKO(TM) AUTOKIT AMYLASE | August 30, 1988 |
| K873520 | baxter healthcare | PARAMAX AMYLASE REAGENT | November 23, 1987 |
| K863052 | j. d. assoc | ALPHA AMYLASE | September 9, 1986 |
| K862640 | electro-nucleonics laboratories | AMYLASE LTS | September 9, 1986 |
| K860530 | sterling diagnostics | AMYLASE REAGENT SET (MODIFIED CARAWAY) | February 28, 1986 |
| K844168 | fisher scientific co | AMYLASE REAGENT CS-726 | November 20, 1984 |
| K843529 | beckman instruments | ASTRA SYSTEMS AMYLASE REAGENT KIT | October 11, 1984 |
| K833864 | sterling biochemical | AMYLASE REAGENT SET-MODIFIED CARAWAY | January 13, 1984 |