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FDA 510(k) Application Details - K050465
Device Classification Name
Enzyme Immunoassay, Cocaine And Cocaine Metabolites
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510(K) Number
K050465
Device Name
Enzyme Immunoassay, Cocaine And Cocaine Metabolites
Applicant
Immunalysis Corporation
829 TOWNE CENTER DR.
POMONA, CA 91767 US
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Contact
MICHAEL VINCENT
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Regulation Number
862.3250
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Classification Product Code
DIO
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Date Received
03/03/2005
Decision Date
08/04/2005
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
TX - Clinical Toxicology
Review Advisory Committee
CH - Clinical Chemistry
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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