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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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