ELECSYS PRECICONTROL THYROAB— 510(k) K092320
Substantially EquivalentRoche Diagnostics
FDA 510(k) clearance K092320 for ELECSYS PRECICONTROL THYROAB, Substantially Equivalent on 2009-11-03. Applicant: Roche Diagnostics. Device class: 1.
Clearance details
- Applicant
- Roche Diagnostics
- 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
- Indianapolis, IN, US
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