SYSTEMATE PLUS CALIBRATOR— 510(k) K925101

Substantially Equivalent

Em Diagnostic Systems, Inc.

FDA 510(k) clearance K925101 for SYSTEMATE PLUS CALIBRATOR, Substantially Equivalent on 1993-02-23. Applicant: Em Diagnostic Systems, Inc..

Clearance details

Applicant: Em Diagnostic Systems, Inc.
Product code: Code JIX
Advisory panel: Clinical Chemistry
Date received: 1992-10-08
Decision date: 1993-02-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Gibbstown, NJ, US

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