EMDS(TM) ELEVATED BILIRUBIN CALIBRATOR # 67627/95— 510(k) K862704

Substantially Equivalent

Em Diagnostic Systems, Inc.

FDA 510(k) clearance K862704 for EMDS(TM) ELEVATED BILIRUBIN CALIBRATOR # 67627/95, Substantially Equivalent on 1986-08-19. Applicant: Em Diagnostic Systems, Inc..

Clearance details

Applicant: Em Diagnostic Systems, Inc.
Product code: Code JIS
Advisory panel: Clinical Chemistry
Date received: 1986-07-15
Decision date: 1986-08-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Gibbstown, NJ, US

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