FDA 510(k) Application Details - K980836

Device Classification Name Enzyme Immunoassay, Cannabinoids

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510(K) Number K980836
Device Name Enzyme Immunoassay, Cannabinoids
Applicant APPLIED TECHNOLOGY VENTURES, L.L.C.
6 TAFT CT., SUITE 150
ROCKVILLE, MD 20850 US
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Contact RICHARD ROBLIN
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Regulation Number 862.3870

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Classification Product Code LDJ
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Date Received 03/04/1998
Decision Date 06/29/1998
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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