HDL CHOLESTEROL REAGENT, MODEL 10211— 510(k) K073497
Substantially EquivalentMedica Corp.
FDA 510(k) clearance K073497 for HDL CHOLESTEROL REAGENT, MODEL 10211, Substantially Equivalent on 2008-04-14. Applicant: Medica Corp.. Device class: 1.
Clearance details
- Applicant
- Medica 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
- Traditional
- Location
- Bedford, MA, US
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