SYSTEMATE(TM) TOTAL BILIRUBIN CATALOG NO. 654XX— 510(k) K897176

Substantially Equivalent

Em Diagnostic Systems, Inc.

FDA 510(k) clearance K897176 for SYSTEMATE(TM) TOTAL BILIRUBIN CATALOG NO. 654XX, Substantially Equivalent on 1990-03-19. Applicant: Em Diagnostic Systems, Inc..

Clearance details

Applicant: Em Diagnostic Systems, Inc.
Product code: Code CIG
Advisory panel: Clinical Chemistry
Date received: 1989-12-27
Decision date: 1990-03-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Gibbstown, NJ, US

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