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FDA 510(k) Application Details - K020210
Device Classification Name
System, Test, Blood Glucose, Over The Counter
More FDA Info for this Device
510(K) Number
K020210
Device Name
System, Test, Blood Glucose, Over The Counter
Applicant
BAYER GROUP DIAGNOSTICS
1884 MILES AVE.
P.O. BOX 70
ELKHART, IN 46515-0070 US
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Contact
GEORGE M TANCOS
Other 510(k) Applications for this Contact
Regulation Number
862.1345
More FDA Info for this Regulation Number
Classification Product Code
NBW
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More FDA Info for this Product Code
Date Received
01/22/2002
Decision Date
04/30/2002
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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