KODAK EKTACHEM DT SLIDES (CA)
FDA 510(k) clearance K870035 · decided 1987-05-12
Clearance details
- K-number
- K870035
- Device name
- KODAK EKTACHEM DT SLIDES (CA)
- Applicant
- Eastman Kodak Company
- Decision
- Substantially Equivalent
- Date received
- 1987-01-05
- Decision date
- 1987-05-12
- Days to decision
- 127 days
- Clearance type
- Traditional
- Product code
- CID
- Device class
- 2
- Regulation number
- 862.1145
- 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
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| Record | Firm | Date |
|---|---|---|
| ALIZARIN SULFONATE, CALCIUM (K801290) | Union Carbide Corp. | 1980-06-30 |
Recalls involving this device
No recalls on record reference this clearance.