SYSTEMATE TOTAL BILIRUBIN CATALOG NO. 65407— 510(k) K895118

Substantially Equivalent

Em Diagnostic Systems, Inc.

FDA 510(k) clearance K895118 for SYSTEMATE TOTAL BILIRUBIN CATALOG NO. 65407, Substantially Equivalent on 1989-10-17. Applicant: Em Diagnostic Systems, Inc..

Clearance details

Applicant: Em Diagnostic Systems, Inc.
Product code: Code CIG
Advisory panel: Clinical Chemistry
Date received: 1989-08-15
Decision date: 1989-10-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Gibbstown, NJ, US

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