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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 K950915
Device Name ABBOTT AXSYM II SYSTEM
Applicant
ABBOTT LABORATORIES
200 ABBOTT PARK RD.
ABBOTT PARK,  IL  60064
Applicant Contact KATHY ZENG
Correspondent
ABBOTT LABORATORIES
200 ABBOTT PARK RD.
ABBOTT PARK,  IL  60064
Correspondent Contact KATHY ZENG
Regulation Number862.2160
Classification Product Code
JJE  
Date Received03/01/1995
Decision Date 05/16/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Toxicology
Type Traditional
Reviewed by Third Party No
Combination Product No
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