ABBOTT QUICKSTART TIBC PRETREATMENT KIT, 5A29-01— 510(k) K913922

Substantially Equivalent

Em Diagnostic Systems, Inc.

FDA 510(k) clearance K913922 for ABBOTT QUICKSTART TIBC PRETREATMENT KIT, 5A29-01, Substantially Equivalent on 1991-09-19. Applicant: Em Diagnostic Systems, Inc..

Clearance details

Applicant: Em Diagnostic Systems, Inc.
Product code: Code JMO
Advisory panel: Clinical Chemistry
Date received: 1991-09-03
Decision date: 1991-09-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Gibbstown, NJ, US

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