SYSTEMATE CREATININE TEST ITEM NUMBER 65413— 510(k) K932160

Substantially Equivalent

Em Diagnostic Systems, Inc.

FDA 510(k) clearance K932160 for SYSTEMATE CREATININE TEST ITEM NUMBER 65413, Substantially Equivalent on 1993-07-09. Applicant: Em Diagnostic Systems, Inc..

Clearance details

Applicant: Em Diagnostic Systems, Inc.
Product code: Code CGX
Advisory panel: Clinical Chemistry
Date received: 1993-05-04
Decision date: 1993-07-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Gibbstown, NJ, US

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