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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name radioassay, vitamin b12
510(k) Number K993571
Device Name BAYER DIAGNOSTICS ACS:180 VB12, BAYER DIAGNOSTICS ADVIA CENTAUE VB12
Applicant
BAYER CORP.
63 NORTH ST.
MEDFIELD,  MA  02052 -1688
Applicant Contact THOMAS F FLYNN
Correspondent
BAYER CORP.
63 NORTH ST.
MEDFIELD,  MA  02052 -1688
Correspondent Contact THOMAS F FLYNN
Regulation Number862.1810
Classification Product Code
CDD  
Date Received10/21/1999
Decision Date 12/16/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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