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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name enzyme linked immunoabsorbent assay, toxoplasma gondii
510(k) Number K954575
Device Name AXSYM TOXO IGG ANTIBODY ASSAY
Applicant
ABBOTT LABORATORIES
100 ABBOTT MALL
BUFFALO,  NY  14225
Applicant Contact JOANNE RUPPRECHT
Correspondent
ABBOTT LABORATORIES
100 ABBOTT MALL
BUFFALO,  NY  14225
Correspondent Contact JOANNE RUPPRECHT
Regulation Number866.3780
Classification Product Code
LGD  
Date Received10/02/1995
Decision Date 08/16/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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