CHOLESTEROL (CHOL) TEST ITEM NO. 65410— 510(k) K935136

Name: FDA 510(k) clearance K935136
Creator: U.S. Food and Drug Administration
Published: 1993-12-16

Substantially Equivalent

Em Diagnostic Systems, Inc.

FDA 510(k) clearance K935136 for CHOLESTEROL (CHOL) TEST ITEM NO. 65410, Substantially Equivalent on 1993-12-16. Applicant: Em Diagnostic Systems, Inc.. Device class: 1.

Clearance details

Applicant: Em Diagnostic Systems, Inc.
Product code: Code CHH
Device class: Class 1
Regulation: 21 CFR 862.1175
Advisory panel: Clinical Chemistry
Date received: 1993-10-28
Decision date: 1993-12-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Gibbstown, NJ, US

Download summary PDF View on FDA.gov ↗

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