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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name test, epithelial ovarian tumor-associated antigen (ca125)
510(k) Number K964020
Device Name AXSYM CA 125
Applicant
ABBOTT LABORATORIES
DEPT 49C, BLDG. AP31
200 ABBOTT RD.
ABBOTT PARK,  IL  60064 -3537
Applicant Contact JOY C SONSALLA
Correspondent
ABBOTT LABORATORIES
DEPT 49C, BLDG. AP31
200 ABBOTT RD.
ABBOTT PARK,  IL  60064 -3537
Correspondent Contact JOY C SONSALLA
Regulation Number866.6010
Classification Product Code
LTK  
Date Received10/07/1996
Decision Date 11/04/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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