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FDA 510(k) Application Details - K093114
Device Classification Name
Enzyme Immunoassay, Amphetamine
More FDA Info for this Device
510(K) Number
K093114
Device Name
Enzyme Immunoassay, Amphetamine
Applicant
MICROGENICS CORP.
46360 FREMONT BLVD
FREMONT, CA 94538 US
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Contact
HEWUAN TAKKELE
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
10/01/2009
Decision Date
05/12/2010
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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