ABBOTT QUICKSTART ALANINE AMINOTRANSFER— 510(k) K913846

Substantially Equivalent

Em Diagnostic Systems, Inc.

FDA 510(k) clearance K913846 for ABBOTT QUICKSTART ALANINE AMINOTRANSFER, Substantially Equivalent on 1991-09-19. Applicant: Em Diagnostic Systems, Inc..

Clearance details

Applicant
Em Diagnostic Systems, Inc.
Product code
Code CKA
Advisory panel
Clinical Chemistry
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Gibbstown, NJ, US
Download summary PDFView on FDA.gov ↗

Data sourced from openFDA. This site is unofficial and independent of the FDA.