ULTRA CHEM ENZYMATIC TRIGLYCERIDE— 510(k) K841471

Name: FDA 510(k) clearance K841471
Creator: U.S. Food and Drug Administration
Published: 1984-05-16

Substantially Equivalent

Em Diagnostic Systems, Inc.

FDA 510(k) clearance K841471 for ULTRA CHEM ENZYMATIC TRIGLYCERIDE, Substantially Equivalent on 1984-05-16. Applicant: Em Diagnostic Systems, Inc.. Device class: 1.

Clearance details

Applicant: Em Diagnostic Systems, Inc.
Product code: Code CDT
Device class: Class 1
Regulation: 21 CFR 862.1705
Advisory panel: Clinical Chemistry
Date received: 1984-04-09
Decision date: 1984-05-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

Download summary PDF View on FDA.gov ↗

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