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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name analyzer, chemistry (photometric, discrete), for clinical use
510(k) Number K882914
Device Name VISTA INSTRUMENT
Applicant
ABBOTT LABORATORIES
ONE ABBOTT PARK RD.
ABBOTT PARK,  IL  60064 -3500
Applicant Contact MARY ZORC
Correspondent
ABBOTT LABORATORIES
ONE ABBOTT PARK RD.
ABBOTT PARK,  IL  60064 -3500
Correspondent Contact MARY ZORC
Regulation Number862.2160
Classification Product Code
JJE  
Date Received07/12/1988
Decision Date 08/30/1988
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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