ACS LH2 IMMUNOASSAY— 510(k) K962041
Substantially EquivalentCiba Corning Diagnostics Corp.
FDA 510(k) clearance K962041 for ACS LH2 IMMUNOASSAY, Substantially Equivalent on 1996-06-21. Applicant: Ciba Corning Diagnostics Corp.. Device class: 1.
Clearance details
- Applicant
- Ciba Corning Diagnostics Corp.
- Product code
- Code CEP
- Device class
- Class 1
- Regulation
- 21 CFR 862.1485
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Irvine, CA, US
Recent devices under product code CEP
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