ELECSYS VITAMIN B12 IMMUNOASSAY, CALSET II AND CALCHECK— 510(k) K060755
Substantially EquivalentRoche Diagnostics Corp.
FDA 510(k) clearance K060755 for ELECSYS VITAMIN B12 IMMUNOASSAY, CALSET II AND CALCHECK, Substantially Equivalent on 2006-04-10. Applicant: Roche Diagnostics Corp.. Device class: 2.
Clearance details
- Applicant
- Roche Diagnostics Corp.
- Product code
- Code CDD
- Device class
- Class 2
- Regulation
- 21 CFR 862.1810
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Indianapolis, IN, US
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More clearances from Roche Diagnostics Corp.
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