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FDA 510(k) Application Details - K024062
Device Classification Name
Glucose Oxidase, Glucose
More FDA Info for this Device
510(K) Number
K024062
Device Name
Glucose Oxidase, Glucose
Applicant
BAYER CORP.
1884 MILES AVE.
P.O. BOX 70
ELKHART, IN 46515-0070 US
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Contact
GEORGE M TANCOS
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Regulation Number
862.1345
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Classification Product Code
CGA
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More FDA Info for this Product Code
Date Received
12/09/2002
Decision Date
03/03/2003
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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