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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Visual, Pregnancy Hcg, Prescription Use
510(k) Number K935673
Device Name AXSYM TOTAL B-HCG
Applicant
ABBOTT LABORATORIES
ONE ABBOTT PARK RD.
D389, AP30
ABBOTT PARK,  IL  60064
Applicant Contact JOY C SONSALLA
Correspondent
ABBOTT LABORATORIES
ONE ABBOTT PARK RD.
D389, AP30
ABBOTT PARK,  IL  60064
Correspondent Contact JOY C SONSALLA
Regulation Number862.1155
Classification Product Code
JHI  
Date Received11/26/1993
Decision Date 06/21/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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