BIOTROL HDL CHOLESTEROL PRECIPITATION REAGENT— 510(k) K904184
Substantially EquivalentBiotron U.S.A., Inc.
FDA 510(k) clearance K904184 for BIOTROL HDL CHOLESTEROL PRECIPITATION REAGENT, Substantially Equivalent on 1990-11-28. Applicant: Biotron U.S.A., Inc.. Device class: 1.
Clearance details
- Applicant
- Biotron U.S.A., Inc.
- 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
- West Chester, PA, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.