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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name automated urinalysis system
510(k) Number K031947
Device Name BAYER CLINITEK STATUS ANALYZER
Applicant
BAYER HEALTHCARE, LLC
63 NORTH ST.
MEDFIELD,  MA  02052 -1688
Applicant Contact MARY E GRAY
Correspondent
BAYER HEALTHCARE, LLC
63 NORTH ST.
MEDFIELD,  MA  02052 -1688
Correspondent Contact MARY E GRAY
Regulation Number862.2900
Classification Product Code
KQO  
Subsequent Product Codes
JIR   NFZ  
Date Received06/24/2003
Decision Date 12/19/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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