ZEFAZONE SUSCEPTIBILITY POWDER
FDA 510(k) clearance K900455 · decided 1990-02-09
Clearance details
- K-number
- K900455
- Device name
- ZEFAZONE SUSCEPTIBILITY POWDER
- Applicant
- The Upjohn Co.
- Decision
- Substantially Equivalent
- Date received
- 1990-01-30
- Decision date
- 1990-02-09
- Days to decision
- 10 days
- Clearance type
- Traditional
- Product code
- LOP
- Device class
- 2
- Regulation number
- 866.1640
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Kalamazoo, MI, 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 |
|---|---|---|
| TROBICIN SUSCEPTIBILITY POWDER (K902004) | The Upjohn Co. | 1990-05-15 |
| STOCK ANTIMICROBIC SOLUTIONS (K810471) | Cathra International, Inc. | 1981-04-01 |
Recalls involving this device
No recalls on record reference this clearance.