MODIFIED HI CHEM AMYLASE REAGENT (PRODUCT #88129)
FDA 510(k) clearance K895555 · decided 1989-12-22
Clearance details
- K-number
- K895555
- Device name
- MODIFIED HI CHEM AMYLASE REAGENT (PRODUCT #88129)
- Applicant
- Hichem Diagnostics
- Decision
- Substantially Equivalent
- Date received
- 1989-09-06
- Decision date
- 1989-12-22
- Days to decision
- 107 days
- Clearance type
- Traditional
- Product code
- CJA
- Device class
- 2
- Regulation number
- 862.1070
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Brea, CA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| AMYLASE REAGENT KIT FOR ASTRA SYSTEMS (K884226) | A-Kem, Inc. | 1988-12-09 |
| WAKO(TM) AUTOKIT AMYLASE (K883059) | Wako Chemicals USA, Inc. | 1988-08-30 |
| PARAMAX AMYLASE REAGENT (K873520) | Baxter Healthcare Corp | 1987-11-23 |
| ALPHA AMYLASE (K863052) | J. D. Assoc. | 1986-09-09 |
| AMYLASE LTS (K862640) | Electro-Nucleonics Laboratories, Inc. | 1986-09-09 |
| AMYLASE REAGENT SET (MODIFIED CARAWAY) (K860530) | Sterling Diagnostics, Inc. | 1986-02-28 |
| AMYLASE REAGENT CS-726 (K844168) | Fisher Scientific Co., LLC | 1984-11-20 |
| ASTRA SYSTEMS AMYLASE REAGENT KIT (K843529) | Beckman Instruments, Inc. | 1984-10-11 |
| AMYLASE REAGENT SET-MODIFIED CARAWAY (K833864) | Sterling Biochemical, Inc. | 1984-01-13 |
Recalls involving this device
No recalls on record reference this clearance.