Tina-quant Lipoprotein(a) Gen.2 Molarity— 510(k) K241220
Substantially EquivalentRoche Diagnostics Operations
FDA 510(k) clearance K241220 for Tina-quant Lipoprotein(a) Gen.2 Molarity, Substantially Equivalent on 2025-01-24. Applicant: Roche Diagnostics Operations. Device class: 2.
Clearance details
- Applicant
- Roche Diagnostics Operations
- Product code
- Code DFC
- Device class
- Class 2
- Regulation
- 21 CFR 866.5600
- Advisory panel
- Immunology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Indianapolis, IN, US
Recent devices under product code DFC
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More clearances from Roche Diagnostics Operations
view allData sourced from openFDA. This site is unofficial and independent of the FDA.