CERTAIN COMPLETE LEVELS 1,2, AND 3; CVM LEVELS 1,2,3,4, AND 5— 510(k) K970956
Substantially EquivalentChiron Diagnostics Corp.
FDA 510(k) clearance K970956 for CERTAIN COMPLETE LEVELS 1,2, AND 3; CVM LEVELS 1,2,3,4, AND 5, Substantially Equivalent on 1997-04-08. Applicant: Chiron Diagnostics Corp.. Device class: 1.
Clearance details
- Applicant
- Chiron Diagnostics Corp.
- Product code
- Code JJY
- Device class
- Class 1
- Regulation
- 21 CFR 862.1660
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Medfield, MA, US
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