HDL CHOLESTEROL REAGENT— 510(k) K911406
Substantially EquivalentGenzyme Corp.
FDA 510(k) clearance K911406 for HDL CHOLESTEROL REAGENT, Substantially Equivalent on 1991-05-22. Applicant: Genzyme Corp.. Device class: 1.
Clearance details
- Applicant
- Genzyme Corp.
- Product code
- Code LBR
- Device class
- Class 1
- Regulation
- 21 CFR 862.1475
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Cambridge, MA, US
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More clearances from Genzyme Corp.
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