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FDA 510(k) Application Details - K023584
Device Classification Name
System, Test, Blood Glucose, Over The Counter
More FDA Info for this Device
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
Other 510(k) Applications for this Company
Contact
GEORGE M TANCROS
Other 510(k) Applications for this Contact
Regulation Number
862.1345
More FDA Info for this Regulation Number
Classification Product Code
NBW
Other 510(k) Applications for this Device
More FDA Info for this Product Code
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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