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FDA 510(k) Application Details - K032575
Device Classification Name
Enzyme Immunoassay, Amphetamine
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510(K) Number
K032575
Device Name
Enzyme Immunoassay, Amphetamine
Applicant
W.H.P.M., INC.
163 CABOT ST.
BEVERLY, MA 01915 US
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Contact
FRAN WHITE
Other 510(k) Applications for this Contact
Regulation Number
862.3100
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Classification Product Code
DKZ
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More FDA Info for this Product Code
Date Received
08/20/2003
Decision Date
05/19/2004
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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