SYNCHRON CX SYSTEMS (LAP) REAGENT KIT
FDA 510(k) clearance K895850 · decided 1989-12-05
Clearance details
- K-number
- K895850
- Device name
- SYNCHRON CX SYSTEMS (LAP) REAGENT KIT
- Applicant
- Beckman Instruments, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1989-10-03
- Decision date
- 1989-12-05
- Days to decision
- 63 days
- Clearance type
- Traditional
- Product code
- JGG
- Device class
- 1
- Regulation number
- 862.1460
- 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 |
|---|---|---|
| LEUCINE AMINOPEPTIDASE REAGENT (K844965) | Alladin Diagnostic, Inc. | 1985-03-05 |
Recalls involving this device
No recalls on record reference this clearance.