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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Test, Thyroid Autoantibody
510(k) Number K003291
Device Name BAYER DIAGNOSTICS ACS:180 AND ADVIA CENTAUR ANTI-TPO ASSAY
Applicant
BAYER DIAGNOSTICS CORP.
63 NORTH ST.
MEDFIELD,  MA  02052
Applicant Contact William J Pignato
Correspondent
BAYER DIAGNOSTICS CORP.
63 NORTH ST.
MEDFIELD,  MA  02052
Correspondent Contact William J Pignato
Regulation Number866.5870
Classification Product Code
JZO  
Date Received10/20/2000
Decision Date 12/05/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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