KODAK EKTACHEM CLIN. CHEM. SLIDES (ALB)
FDA 510(k) clearance K812030 · decided 1981-08-03
Clearance details
- K-number
- K812030
- Device name
- KODAK EKTACHEM CLIN. CHEM. SLIDES (ALB)
- Applicant
- Eastman Kodak Company
- Decision
- Substantially Equivalent
- Date received
- 1981-07-20
- Decision date
- 1981-08-03
- Days to decision
- 14 days
- Clearance type
- Traditional
- Product code
- CIX
- Device class
- 2
- Regulation number
- 862.1035
- 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 ALB Slides, 90 slides/pack; catalog number 1988211 VITROS ALB Sl recall (Z-0294-2014) | Ortho-Clinical Diagnostics | 2013-11-15 |