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FDA 510(k) Application Details - K042808
Device Classification Name
Enzyme Immunoassay, Carbamazepine
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510(K) Number
K042808
Device Name
Enzyme Immunoassay, Carbamazepine
Applicant
BAYER HEALTHCARE, LLC
511 BENEDICT AVE.
TARRYTOWN, NY 10591 US
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Contact
ANDRES HOLLE
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Regulation Number
862.3645
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Classification Product Code
KLT
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More FDA Info for this Product Code
Date Received
10/12/2004
Decision Date
02/08/2005
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
TX - Clinical Toxicology
Review Advisory Committee
CH - Clinical Chemistry
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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