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FDA 510(k) Application Details - K023780
Device Classification Name
Calibrators, Drug Specific
More FDA Info for this Device
510(K) Number
K023780
Device Name
Calibrators, Drug Specific
Applicant
MICROGENICS CORP.
46360 FREMONT BLVD.
FREMONT, CA 94538 US
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Contact
LAKSHMI ANNE
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Regulation Number
862.3200
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Classification Product Code
DLJ
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More FDA Info for this Product Code
Date Received
11/12/2002
Decision Date
02/10/2003
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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