IQ HDL CHOLESTEROL— 510(k) K881891

Name: FDA 510(k) clearance K881891
Creator: U.S. Food and Drug Administration
Published: 1988-06-10

Substantially Equivalent

Bd Becton Dickinson Vacutainer Systems Preanalytic

FDA 510(k) clearance K881891 for IQ HDL CHOLESTEROL, Substantially Equivalent on 1988-06-10. Applicant: Bd Becton Dickinson Vacutainer Systems Preanalytic. Device class: 1.

Clearance details

Applicant: Bd Becton Dickinson Vacutainer Systems Preanalytic
Product code: Code LBS
Device class: Class 1
Regulation: 21 CFR 862.1475
Advisory panel: Clinical Chemistry
Date received: 1988-05-05
Decision date: 1988-06-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Franklin Lakes, NJ, US

Download summary PDF View on FDA.gov ↗

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