ELITECH CLINCAL SYSTEMS CHOLESTEROL HDL SL 2G, HDL 2G CALIBRATOR, LDL SL 2G, LDL 2G CALIBRATOR, ELITROL II & ELITECH SYS— 510(k) K103747
Substantially EquivalentElitechgroup Seppim S.A.S.
FDA 510(k) clearance K103747 for ELITECH CLINCAL SYSTEMS CHOLESTEROL HDL SL 2G, HDL 2G CALIBRATOR, LDL SL 2G, LDL 2G CALIBRATOR, ELITROL II & ELITECH SYS, Substantially Equivalent on 2011-08-31. Applicant: Elitechgroup Seppim S.A.S.. Device class: 1.
Clearance details
- Applicant
- Elitechgroup Seppim S.A.S.
- 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
- Bothell, WA, US
Recent devices under product code LBS
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