MEASLES-COMPLEMENT FIX ANTIGEN & NEGATIVE CLT
FDA 510(k) clearance K852932 · decided 1985-11-12
Clearance details
- K-number
- K852932
- Device name
- MEASLES-COMPLEMENT FIX ANTIGEN & NEGATIVE CLT
- Applicant
- Microbix Biosystems, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1985-07-09
- Decision date
- 1985-11-12
- Days to decision
- 126 days
- Clearance type
- Traditional
- Product code
- GRF
- Device class
- 1
- Regulation number
- 866.3520
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Canada, CA
- 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 |
|---|---|---|
| THREE SPIKE CUP (K922870) | Osteo Technology, Inc. | 1993-04-08 |
Recalls involving this device
No recalls on record reference this clearance.