KODAK EKTACHEM DT SLIDES (LIPASE)
FDA 510(k) clearance K913196 · decided 1991-09-25
Clearance details
- K-number
- K913196
- Device name
- KODAK EKTACHEM DT SLIDES (LIPASE)
- Applicant
- Eastman Kodak Company
- Decision
- Substantially Equivalent
- Date received
- 1991-07-18
- Decision date
- 1991-09-25
- Days to decision
- 69 days
- Clearance type
- Traditional
- Product code
- CHT
- Device class
- 1
- Regulation number
- 862.1165
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Rochester, NY, 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 |
|---|---|---|
| CAT-A-KIT (K760920) | The Upjohn Co. | 1976-11-09 |
Recalls involving this device
No recalls on record reference this clearance.