HDL-CHOLESTEROL PLUS 2ND GENERATION— 510(k) K033610
Substantially EquivalentRoche Diagnostics Corp.
FDA 510(k) clearance K033610 for HDL-CHOLESTEROL PLUS 2ND GENERATION, Substantially Equivalent on 2003-12-05. Applicant: Roche Diagnostics Corp.. Device class: 1.
Clearance details
- Applicant
- Roche Diagnostics Corp.
- Product code
- Code LBS
- Device class
- Class 1
- Regulation
- 21 CFR 862.1475
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Indianapolis, IN, US
Recent devices under product code LBS
view allMore clearances from Roche Diagnostics Corp.
view allData sourced from openFDA. This site is unofficial and independent of the FDA.