NEONATAL BILIRUBIN(NBIL) TEST PACK 67661/95— 510(k) K855079

Substantially Equivalent

Em Diagnostic Systems, Inc.

FDA 510(k) clearance K855079 for NEONATAL BILIRUBIN(NBIL) TEST PACK 67661/95, Substantially Equivalent on 1986-03-05. Applicant: Em Diagnostic Systems, Inc..

Clearance details

Applicant: Em Diagnostic Systems, Inc.
Product code: Code CIG
Advisory panel: Clinical Chemistry
Date received: 1985-12-19
Decision date: 1986-03-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Gibbstown, NJ, US

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