KODAK EKTACHEM DT SLIDES (URCR)
FDA 510(k) clearance K934071 · decided 1994-03-21
Clearance details
- K-number
- K934071
- Device name
- KODAK EKTACHEM DT SLIDES (URCR)
- Applicant
- Eastman Kodak Company
- Decision
- Substantially Equivalent
- Date received
- 1993-08-20
- Decision date
- 1994-03-21
- Days to decision
- 213 days
- Clearance type
- Traditional
- Product code
- CGX
- 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
| Record | Firm | Date |
|---|---|---|
| VITROS Chemistry Products DT Calibrator Kit, REF/Catalog No. 195 7927, IVD --- Common/Usua recall (Z-0917-2012) | Ortho-Clinical Diagnostics | 2012-01-27 |