CHOLESTECH LIPID MONITOR SYST, TRIGLYCERIDES TEST— 510(k) K914033

Name: FDA 510(k) clearance K914033
Creator: U.S. Food and Drug Administration
Published: 1991-09-27

Substantially Equivalent

Cholestech Corp.

FDA 510(k) clearance K914033 for CHOLESTECH LIPID MONITOR SYST, TRIGLYCERIDES TEST, Substantially Equivalent on 1991-09-27. Applicant: Cholestech Corp.. Device class: 1.

Clearance details

Applicant: Cholestech Corp.
Product code: Code JGY
Device class: Class 1
Regulation: 21 CFR 862.1705
Advisory panel: Clinical Chemistry
Date received: 1991-09-10
Decision date: 1991-09-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hayward, CA, US

Download summary PDF View on FDA.gov ↗

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