EMDS(TM) CREATININE(CREA) TESTPACKS, #67669/95— 510(k) K863738

Substantially Equivalent

Em Diagnostic Systems, Inc.

FDA 510(k) clearance K863738 for EMDS(TM) CREATININE(CREA) TESTPACKS, #67669/95, Substantially Equivalent on 1986-11-05. Applicant: Em Diagnostic Systems, Inc..

Clearance details

Applicant: Em Diagnostic Systems, Inc.
Product code: Code CGX
Advisory panel: Clinical Chemistry
Date received: 1986-09-23
Decision date: 1986-11-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Gibbstown, NJ, US

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