510(k) K904184— BIOTROL HDL CHOLESTEROL PRECIPITATION REAGENT

Substantially Equivalent

Biotron U.S.A., Inc.

Clearance details

Applicant: Biotron U.S.A., Inc.
Product code: Code LBR
Advisory panel: Clinical Chemistry
Date received: 1990-09-12
Decision date: 1990-11-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: West Chester, PA, US

Download summary PDF View on FDA.gov ↗

Data sourced from openFDA. This site is unofficial and independent of the FDA.