TINA-QUANT FERRITIN GEN. 4— 510(k) K100538
Substantially EquivalentRoche Diagnostics
FDA 510(k) clearance K100538 for TINA-QUANT FERRITIN GEN. 4, Substantially Equivalent on 2010-06-22. Applicant: Roche Diagnostics. Device class: 2.
Clearance details
- Applicant
- Roche Diagnostics
- Product code
- Code DBF
- Device class
- Class 2
- Regulation
- 21 CFR 866.5340
- Advisory panel
- Immunology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Indianapolis, IN, US
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