FDA 510(k) Application Details - K023584

Device Classification Name System, Test, Blood Glucose, Over The Counter

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510(K) Number K023584
Device Name System, Test, Blood Glucose, Over The Counter
Applicant BAYER CORP.
1884 MILES AVE.
P.O. BOX 70
ELKHART, IN 46515-0070 US
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Contact GEORGE M TANCROS
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Regulation Number 862.1345

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Classification Product Code NBW
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Date Received 10/25/2002
Decision Date 11/20/2002
Decision SESE - SUBST EQUIV
Classification Advisory Committee CH - Clinical Chemistry
Review Advisory Committee CH - Clinical Chemistry
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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