CJA — Amyloclastic, Amylase Class II
FDA Device Classification
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 |