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FDA 510(k) Application Details - K991516
Device Classification Name
Enzyme Immunoassay, Cannabinoids
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510(K) Number
K991516
Device Name
Enzyme Immunoassay, Cannabinoids
Applicant
MICRODIAGNOSTICS, INC.
28062 FORBES ROAD, SUITE B
LAGUNA NIGUEL, CA 92677 US
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Contact
ROY CHUNG
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Regulation Number
862.3870
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Classification Product Code
LDJ
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More FDA Info for this Product Code
Date Received
04/30/1999
Decision Date
08/05/1999
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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