CAT-A-KIT
FDA 510(k) clearance K760920 · decided 1976-11-09
Clearance details
- K-number
- K760920
- Device name
- CAT-A-KIT
- Applicant
- The Upjohn Co.
- Decision
- Substantially Equivalent
- Date received
- 1976-10-28
- Decision date
- 1976-11-09
- Days to decision
- 12 days
- Clearance type
- Traditional
- Product code
- CHT
- Device class
- 1
- Regulation number
- 862.1165
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Walker, 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 |
|---|---|---|
| KODAK EKTACHEM DT SLIDES (LIPASE) (K913196) | Eastman Kodak Company | 1991-09-25 |
Recalls involving this device
No recalls on record reference this clearance.