ANEMIA I, II— 510(k) K911984
Substantially EquivalentCiba Corning Diagnostics Corp.
FDA 510(k) clearance K911984 for ANEMIA I, II, Substantially Equivalent on 1991-06-13. Applicant: Ciba Corning Diagnostics Corp.. Device class: 1.
Clearance details
- Applicant
- Ciba Corning Diagnostics Corp.
- Product code
- Code JJY
- Device class
- Class 1
- Regulation
- 21 CFR 862.1660
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- East Walpole, MA, US
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