CERTAIN(R) ELITE LEVEL 1, 2 AND 3— 510(k) K946224
Substantially EquivalentCiba Corning Diagnostics Corp.
FDA 510(k) clearance K946224 for CERTAIN(R) ELITE LEVEL 1, 2 AND 3, Substantially Equivalent on 1995-01-30. Applicant: Ciba Corning Diagnostics Corp.. Device class: 1.
Clearance details
- Applicant
- Ciba Corning Diagnostics Corp.
- Product code
- Code JJS
- 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
Recent devices under product code JJS
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