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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
Original Applicant
BAYER DIAGNOSTICS CORP.
63 north st.
medfield,  MA  02052
Original Contact william j pignato
Regulation Number866.5870
Classification Product Code
JZO  
Date Received10/20/2000
Decision Date 12/05/2000
Decision substantially equivalent - CLIA submission (CS)
Classification Advisory Committee Immunology
Review Advisory Committee Immunology
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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