TOTAL CHOLESTEROL AND HDL CHOLESTEROL PANEL— 510(k) K946063

Name: FDA 510(k) clearance K946063
Creator: U.S. Food and Drug Administration
Published: 1995-02-22

Substantially Equivalent

Cholestech Corp.

FDA 510(k) clearance K946063 for TOTAL CHOLESTEROL AND HDL CHOLESTEROL PANEL, Substantially Equivalent on 1995-02-22. Applicant: Cholestech Corp.. Device class: 1.

Clearance details

Applicant: Cholestech Corp.
Product code: Code CHH
Device class: Class 1
Regulation: 21 CFR 862.1175
Advisory panel: Clinical Chemistry
Date received: 1994-11-15
Decision date: 1995-02-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hayward, CA, US

Download summary PDF View on FDA.gov ↗

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