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FDA 510(k) Application Details - K090282
Device Classification Name
Enzyme Immunoassay, Lidocaine
More FDA Info for this Device
510(K) Number
K090282
Device Name
Enzyme Immunoassay, Lidocaine
Applicant
THERMO FISHER SCIENTIFIC INC.
7998 GEORGETOWN ROAD
SUITE 1000
INDIANAPOLIS, IN 46268-9046 US
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Contact
JACK ROGERS
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Regulation Number
862.3555
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Classification Product Code
KLR
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More FDA Info for this Product Code
Date Received
02/05/2009
Decision Date
05/29/2009
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
TX - Clinical Toxicology
Review Advisory Committee
TX - Clinical Toxicology
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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