ABBOTT QUICKSTART ALBUMIN TEST (ALBG) ITEM #5A37— 510(k) K913920

Substantially Equivalent

Em Diagnostic Systems, Inc.

FDA 510(k) clearance K913920 for ABBOTT QUICKSTART ALBUMIN TEST (ALBG) ITEM #5A37, Substantially Equivalent on 1991-09-27. Applicant: Em Diagnostic Systems, Inc..

Clearance details

Applicant: Em Diagnostic Systems, Inc.
Product code: Code CIX
Advisory panel: Clinical Chemistry
Date received: 1991-09-03
Decision date: 1991-09-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Gibbstown, NJ, US

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