ENZYMATIC TRIGLYCERIDES GPO-TRINDER METHOD— 510(k) K871301

Name: FDA 510(k) clearance K871301
Creator: U.S. Food and Drug Administration
Published: 1987-04-22

Substantially Equivalent

American Monitor Corp.

FDA 510(k) clearance K871301 for ENZYMATIC TRIGLYCERIDES GPO-TRINDER METHOD, Substantially Equivalent on 1987-04-22. Applicant: American Monitor Corp.. Device class: 1.

Clearance details

Applicant: American Monitor Corp.
Product code: Code CDT
Device class: Class 1
Regulation: 21 CFR 862.1705
Advisory panel: Clinical Chemistry
Date received: 1987-04-01
Decision date: 1987-04-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Indianapolis, IN, US

Download summary PDF View on FDA.gov ↗

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