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FDA 510(k) Application Details - K990870
Device Classification Name
Enzyme Immunoassay, Cannabinoids
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510(K) Number
K990870
Device Name
Enzyme Immunoassay, Cannabinoids
Applicant
REDWOOD BIOTECH, INC.
520 WEDDELL DRIVE, SUITE 8
SUNNYVALE, CA 94089 US
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Contact
JANIS FREESTONE
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Regulation Number
862.3870
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Classification Product Code
LDJ
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Date Received
03/16/1999
Decision Date
04/27/1999
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
TX - Clinical Toxicology
Review Advisory Committee
TX - Clinical Toxicology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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