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FDA 510(k) Application Details - K143187
Device Classification Name
Enzyme Immunoassay, Opiates
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510(K) Number
K143187
Device Name
Enzyme Immunoassay, Opiates
Applicant
Healgen Scientific LLC
5213 Maple St
Bellaire, TX 77401 US
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Contact
Jianqiu Fang
Other 510(k) Applications for this Contact
Regulation Number
862.3650
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Classification Product Code
DJG
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More FDA Info for this Product Code
Date Received
11/05/2014
Decision Date
01/27/2015
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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