SYSTEMATE DIRECT BILIRUBIN TEST TECHNICON RA 1000— 510(k) K922856

Substantially Equivalent

Em Diagnostic Systems, Inc.

FDA 510(k) clearance K922856 for SYSTEMATE DIRECT BILIRUBIN TEST TECHNICON RA 1000, Substantially Equivalent on 1992-09-09. Applicant: Em Diagnostic Systems, Inc..

Clearance details

Applicant: Em Diagnostic Systems, Inc.
Product code: Code CIG
Advisory panel: Clinical Chemistry
Date received: 1992-06-15
Decision date: 1992-09-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Gibbstown, NJ, US

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