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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
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