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FDA 510(k) Application Details - K013959
Device Classification Name
Calibrators, Drug Mixture
More FDA Info for this Device
510(K) Number
K013959
Device Name
Calibrators, Drug Mixture
Applicant
BAYER DIAGNOSTICS CORP.
511 BENEDICT AVE.
TARRYTOWN, NY 10591-5097 US
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Contact
KENNETH T EDDS
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Regulation Number
862.3200
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Classification Product Code
DKB
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More FDA Info for this Product Code
Date Received
11/30/2001
Decision Date
01/29/2002
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
TX - Clinical Toxicology
Review Advisory Committee
TX - Clinical Toxicology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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