FDA 510(k) Application Details - K002263

Device Classification Name Enzyme Immunoassay, Cannabinoids

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510(K) Number K002263
Device Name Enzyme Immunoassay, Cannabinoids
Applicant BRANAN MEDICAL CORP.
10015 MUIRLANDS RD., SUITE E
IRVINE, CA 92618 US
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Contact RAPHAEL WONG
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Regulation Number 862.3870

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Classification Product Code LDJ
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Date Received 07/25/2000
Decision Date 11/27/2000
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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