FDA 510(k) Application Details - K012205

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

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510(K) Number K012205
Device Name System, Test, Blood Glucose, Over The Counter
Applicant BAYER CORP.
1884 MILES AVE.
ELKHART, IN 46514 US
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Contact GEORGE M TANCOS
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Regulation Number 862.1345

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Classification Product Code NBW
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Date Received 07/16/2001
Decision Date 09/12/2001
Decision SESE - SUBST EQUIV
Classification Advisory Committee CH - Clinical Chemistry
Review Advisory Committee CH - Clinical Chemistry
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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