THREE SPIKE CUP
FDA 510(k) clearance K922870 · decided 1993-04-08
Clearance details
- K-number
- K922870
- Device name
- THREE SPIKE CUP
- Applicant
- Osteo Technology, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1992-06-04
- Decision date
- 1993-04-08
- Days to decision
- 308 days
- Clearance type
- Traditional
- Product code
- GRF
- Device class
- 1
- Regulation number
- 866.3520
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Timonium, MD, 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 |
|---|---|---|
| MEASLES-COMPLEMENT FIX ANTIGEN & NEGATIVE CLT (K852932) | Microbix Biosystems, Inc. | 1985-11-12 |
Recalls involving this device
No recalls on record reference this clearance.