CHEMTRAK ACCUMETER CHOLESTEROL TEST— 510(k) K905405

Name: FDA 510(k) clearance K905405
Creator: U.S. Food and Drug Administration
Published: 1991-03-19

Substantially Equivalent

Chemtrak, Inc.

FDA 510(k) clearance K905405 for CHEMTRAK ACCUMETER CHOLESTEROL TEST, Substantially Equivalent on 1991-03-19. Applicant: Chemtrak, Inc.. Device class: 1.

Clearance details

Applicant: Chemtrak, Inc.
Product code: Code CHH
Device class: Class 1
Regulation: 21 CFR 862.1175
Advisory panel: Clinical Chemistry
Date received: 1990-12-03
Decision date: 1991-03-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sunnyvale, CA, US

Download summary PDF View on FDA.gov ↗

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