KODAK EXTACHEM CLINICAL CHEMISTRY SLIDES (FE)
FDA 510(k) clearance K910143 · decided 1991-02-04
Clearance details
- K-number
- K910143
- Device name
- KODAK EXTACHEM CLINICAL CHEMISTRY SLIDES (FE)
- Applicant
- Eastman Kodak Company
- Decision
- Substantially Equivalent
- Date received
- 1991-01-14
- Decision date
- 1991-02-04
- Days to decision
- 21 days
- Clearance type
- Traditional
- Product code
- JIY
- Device class
- 1
- Regulation number
- 862.1410
- 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 Fe Slides packaged as 300 slides/pack catalog number 1515808 and recall (Z-0313-2014) | Ortho-Clinical Diagnostics | 2013-11-15 |