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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Analyzer, Enzyme, For Clinical Use
510(k) Number K931970
Device Name ABBOTT IMX2 ANALYER
Applicant
ABBOTT LABORATORIES
ONE ABBOTT PARK RD.
ABBOTT PARK,  IL  60064 -3500
Applicant Contact MARY SPIEWAK
Correspondent
ABBOTT LABORATORIES
ONE ABBOTT PARK RD.
ABBOTT PARK,  IL  60064 -3500
Correspondent Contact MARY SPIEWAK
Regulation Number862.2500
Classification Product Code
JJI  
Date Received04/22/1993
Decision Date 06/16/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
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