CIBA CORNING ACS; 180 DPD ASSAY— 510(k) K963251
Substantially EquivalentCiba Corning Diagnostics Corp.
FDA 510(k) clearance K963251 for CIBA CORNING ACS; 180 DPD ASSAY, Substantially Equivalent on 1996-10-15. Applicant: Ciba Corning Diagnostics Corp.. Device class: 1.
Clearance details
- Device name as filed
- CIBA CORNING ACS;180 DPD ASSAY
- Applicant
- Ciba Corning Diagnostics Corp.
- Product code
- Code JMM
- Device class
- Class 1
- Regulation
- 21 CFR 862.1400
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Irvine, CA, US
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