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FDA 510(k) Application Details - K030360
Device Classification Name
Enzyme Immunoassay, Cocaine And Cocaine Metabolites
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510(K) Number
K030360
Device Name
Enzyme Immunoassay, Cocaine And Cocaine Metabolites
Applicant
RANDOX LABORATORIES, LTD.
55 DIAMOND RD.
CRUMLIN, COUNTY ANTRIM BT29 4QY GB
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Contact
PAULINE ARMSTRONG
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Regulation Number
862.3250
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Classification Product Code
DIO
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More FDA Info for this Product Code
Date Received
02/03/2003
Decision Date
12/23/2003
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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