EKTACHEM CLINICAL CHEM. SLIDES
FDA 510(k) clearance K840880 · decided 1984-04-18
Clearance details
- K-number
- K840880
- Device name
- EKTACHEM CLINICAL CHEM. SLIDES
- Applicant
- Eastman Kodak Company
- Decision
- Substantially Equivalent
- Date received
- 1984-02-27
- Decision date
- 1984-04-18
- Days to decision
- 51 days
- Clearance type
- Traditional
- Product code
- CIG
- Device class
- 2
- Regulation number
- 862.1110
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Walker, MI, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| VITROS Chemistry Products White Reference Slides, White Correction Factor Slide (WCF), DT recall (Z-1226-2014) | Ortho-Clinical Diagnostics | 2014-03-19 |
| VITROS Chemistry Products TBIL Slides packaged as 300 slides/pack catalog number 8159931 V recall (Z-0324-2014) | Ortho-Clinical Diagnostics | 2013-11-15 |