510(k) K843529
- Device
- Astra Systems Amylase Reagent Kit
- Applicant
- BECKMAN INSTRUMENTS, INC.
- 510(k) number
- K843529
- Product code
- CJA
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1984-10-11
- Date received
- 1984-09-07
- Regulation
- 862.1070
- Classification name
- Amyloclastic, Amylase
- Medical specialty
- Clinical Chemistry
- Review panel
- Clinical Chemistry
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- JACK E SOROKIN
- Address
- P.O. Box 3100 Fullerton CA US 92634 92634
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code CJA#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K895555 | MODIFIED HI CHEM AMYLASE REAGENT (PRODUCT #88129) | Hichem Diagnostics | 1989-12-22 |
| K884226 | AMYLASE REAGENT KIT FOR ASTRA SYSTEMS | A-Kem, Inc. | 1988-12-09 |
| K883059 | WAKO(TM) AUTOKIT AMYLASE | Wako Chemicals USA, Inc. | 1988-08-30 |
| K873520 | PARAMAX AMYLASE REAGENT | Baxter Healthcare Corp | 1987-11-23 |
| K862640 | AMYLASE LTS | Electro-Nucleonics Laboratories, Inc. | 1986-09-09 |
| K863052 | ALPHA AMYLASE | J. D. Assoc. | 1986-09-09 |
| K860530 | AMYLASE REAGENT SET (MODIFIED CARAWAY) | Sterling Diagnostics, Inc. | 1986-02-28 |
| K844168 | AMYLASE REAGENT CS-726 | Fisher Scientific Co., LLC | 1984-11-20 |
| K833864 | AMYLASE REAGENT SET-MODIFIED CARAWAY | Sterling Biochemical, Inc. | 1984-01-13 |