KODAK EKTACHEM DT SLIDES (CRSC)
FDA 510(k) clearance K875191 · decided 1988-02-24
Clearance details
- K-number
- K875191
- Device name
- KODAK EKTACHEM DT SLIDES (CRSC)
- Applicant
- Eastman Kodak Company
- Decision
- Substantially Equivalent
- Date received
- 1987-12-17
- Decision date
- 1988-02-24
- Days to decision
- 69 days
- Clearance type
- Traditional
- Product code
- JFY
- Device class
- 2
- Regulation number
- 862.1225
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Rochester, NY, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.