CHOLESTEROL TEST ITEM# 42374/93, 42322/R1— 510(k) K924508

Substantially Equivalent

Em Diagnostic Systems, Inc.

FDA 510(k) clearance K924508 for CHOLESTEROL TEST ITEM# 42374/93, 42322/R1, Substantially Equivalent on 1993-01-28. Applicant: Em Diagnostic Systems, Inc..

Clearance details

Applicant: Em Diagnostic Systems, Inc.
Product code: Code CHH
Advisory panel: Clinical Chemistry
Date received: 1992-09-04
Decision date: 1993-01-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Gibbstown, NJ, US

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