TINA-QUANT APOLIPOPROTEIN VER.2— 510(k) K013249
Substantially EquivalentRoche Diagnostics Corp.
FDA 510(k) clearance K013249 for TINA-QUANT APOLIPOPROTEIN VER.2, Substantially Equivalent on 2001-11-16. Applicant: Roche Diagnostics Corp.. Device class: 2.
Clearance details
- Applicant
- Roche Diagnostics Corp.
- Product code
- Code DER
- Device class
- Class 2
- Regulation
- 21 CFR 866.5580
- Advisory panel
- Immunology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Indianapolis, IN, US
Recent devices under product code DER
view allMore clearances from Roche Diagnostics Corp.
view allRecalls naming K013249
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K013249.
Data sourced from openFDA. This site is unofficial and independent of the FDA.