HDL-Cholesterol Gen.4— 510(k) K162593
Substantially EquivalentRoche Diagnostics Operations (Rdo)
FDA 510(k) clearance K162593 for HDL-Cholesterol Gen.4, Substantially Equivalent on 2016-10-19. Applicant: Roche Diagnostics Operations (Rdo). Device class: 1.
Clearance details
- Applicant
- Roche Diagnostics Operations (Rdo)
- 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
- Traditional
- Location
- Indianapolis, IN, US
Recent devices under product code LBS
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More clearances from Roche Diagnostics Operations (Rdo)
view allData sourced from openFDA. This site is unofficial and independent of the FDA.