510(k) K873520
- Device
- Paramax Amylase Reagent
- Applicant
- BAXTER HEALTHCARE CORP.
- 510(k) number
- K873520
- Product code
- CJA
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1987-11-23
- Date received
- 1987-09-01
- 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
- KRISTA SMALLEY
- Address
- P.O. Box 25101 Santa Ana CA US 92799 92799
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 |
| 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 |
| K843529 | ASTRA SYSTEMS AMYLASE REAGENT KIT | Beckman Instruments, Inc. | 1984-10-11 |
| K833864 | AMYLASE REAGENT SET-MODIFIED CARAWAY | Sterling Biochemical, Inc. | 1984-01-13 |