DeviceClearance

ABBOTT QUICKSTART DIRECT BILIRUBIN (DBIL) #5A20— 510(k) K913466

Substantially Equivalent

Em Diagnostic Systems, Inc.

FDA 510(k) clearance K913466 for ABBOTT QUICKSTART DIRECT BILIRUBIN (DBIL) #5A20, Substantially Equivalent on 1991-10-25. Applicant: Em Diagnostic Systems, Inc..

Clearance details

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