CIBA CORNING ACS VANCOMYCIN IMMUNOASSAY— 510(k) K951059
Substantially EquivalentCiba Corning Diagnostics Corp.
FDA 510(k) clearance K951059 for CIBA CORNING ACS VANCOMYCIN IMMUNOASSAY, Substantially Equivalent on 1995-06-19. Applicant: Ciba Corning Diagnostics Corp.. Device class: 2.
Clearance details
- Applicant
- Ciba Corning Diagnostics Corp.
- Product code
- Code LEH
- Device class
- Class 2
- Regulation
- 21 CFR 862.3950
- Advisory panel
- Clinical Toxicology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Medfield, MA, US
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