FDA 510(k) Application Details - K061556

Device Classification Name Enzyme Immunoassay, Cannabinoids

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510(K) Number K061556
Device Name Enzyme Immunoassay, Cannabinoids
Applicant AMEDICA BIOTECH, INC.
28301 INDUSTRIAL BLVD SUITE K
HAYWARD, CA 94545 US
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Contact Jeff Chen
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Regulation Number 862.3870

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Classification Product Code LDJ
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Date Received 06/05/2006
Decision Date 07/21/2006
Decision SESE - SUBST EQUIV
Classification Advisory Committee TX - Clinical Toxicology
Review Advisory Committee TX - Clinical Toxicology
Statement / Summary / Purged Status Statement
Type Special
Reviewed By Third Party N
Expedited Review



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