EMDS (TM) HDL CHOLESTEROL ITEM NO. 67679/95— 510(k) K862845

Name: FDA 510(k) clearance K862845
Creator: U.S. Food and Drug Administration
Published: 1986-08-29

Substantially Equivalent

Em Diagnostic Systems, Inc.

FDA 510(k) clearance K862845 for EMDS (TM) HDL CHOLESTEROL ITEM NO. 67679/95, Substantially Equivalent on 1986-08-29. Applicant: Em Diagnostic Systems, Inc.. Device class: 1.

Clearance details

Applicant: Em Diagnostic Systems, Inc.
Product code: Code LBS
Device class: Class 1
Regulation: 21 CFR 862.1475
Advisory panel: Clinical Chemistry
Date received: 1986-07-29
Decision date: 1986-08-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Gibbstown, NJ, US

Download summary PDF View on FDA.gov ↗

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