TDM CONTROL SET— 510(k) K060429
Substantially EquivalentRoche Diagnostics Corp.
FDA 510(k) clearance K060429 for TDM CONTROL SET, Substantially Equivalent on 2006-03-15. Applicant: Roche Diagnostics Corp.. Device class: 1.
Clearance details
- Applicant
- Roche 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
- Abbreviated
- Location
- Indianapolis, IN, US
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