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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Hemoglobin, Automated
510(k) Number K020616
Device Name BAYER RAPIDPOINT 405 SYSTEM
Applicant
BAYER DIAGNOSTICS CORP.
63 NORTH ST.
MEDFIELD,  MA  02052
Applicant Contact THOMAS F FLYNN
Correspondent
BAYER DIAGNOSTICS CORP.
63 NORTH ST.
MEDFIELD,  MA  02052
Correspondent Contact THOMAS F FLYNN
Regulation Number864.5620
Classification Product Code
GKR  
Date Received02/25/2002
Decision Date 07/17/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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