CIBA CORNING ACS CORTISOL IMMUNOASSAY— 510(k) K945367
Substantially EquivalentCiba Corning Diagnostics Corp.
FDA 510(k) clearance K945367 for CIBA CORNING ACS CORTISOL IMMUNOASSAY, Substantially Equivalent on 1995-05-05. Applicant: Ciba Corning Diagnostics Corp.. Device class: 2.
Clearance details
- Applicant
- Ciba Corning Diagnostics Corp.
- Product code
- Code CGR
- Device class
- Class 2
- Regulation
- 21 CFR 862.1205
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Medfield, MA, US
Recent devices under product code CGR
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