FDA 510(k) Application Details - K142408

Device Classification Name Enzyme Immunoassay, Cannabinoids

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510(K) Number K142408
Device Name Enzyme Immunoassay, Cannabinoids
Applicant POLYMED THERAPEUTICS, INC
3040 POST OAK BLVD, SUITE 1110
HOUSTON, TX 77056 US
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Contact FRANK LUO
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Regulation Number 862.3870

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Classification Product Code LDJ
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Date Received 08/28/2014
Decision Date 09/25/2014
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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