CIBA CORNING ACS ESTRADIOL-6 ASSAY— 510(k) K954697
Substantially EquivalentCiba Corning Diagnostics Corp.
FDA 510(k) clearance K954697 for CIBA CORNING ACS ESTRADIOL-6 ASSAY, Substantially Equivalent on 1995-12-13. Applicant: Ciba Corning Diagnostics Corp.. Device class: 1.
Clearance details
- Applicant
- Ciba Corning Diagnostics Corp.
- Product code
- Code CHP
- Device class
- Class 1
- Regulation
- 21 CFR 862.1260
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Medfield, MA, US
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More clearances from Ciba Corning Diagnostics Corp.
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