EMDS TRIGLYCERIDE (TRIG), ITEM NUMBER 65421— 510(k) K893917

Name: FDA 510(k) clearance K893917
Creator: U.S. Food and Drug Administration
Published: 1989-08-28

Substantially Equivalent

Em Diagnostic Systems, Inc.

FDA 510(k) clearance K893917 for EMDS TRIGLYCERIDE (TRIG), ITEM NUMBER 65421, Substantially Equivalent on 1989-08-28. 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: 1989-05-30
Decision date: 1989-08-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Gibbstown, NJ, US

Download summary PDF View on FDA.gov ↗

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