FDA 510(k) Application Details - K110239

Device Classification Name Enzyme Immunoassay, Cannabinoids

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510(K) Number K110239
Device Name Enzyme Immunoassay, Cannabinoids
Applicant Lin-Zhi International, Inc.
670 ALmanor Avenue
Sunnyvale, CA 94085 US
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Contact BERNICE LIN
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Regulation Number 862.3870

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Classification Product Code LDJ
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Date Received 01/26/2011
Decision Date 06/23/2011
Decision SESE - SUBST EQUIV
Classification Advisory Committee TX - Clinical Toxicology
Review Advisory Committee CH - Clinical Chemistry
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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