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FDA 510(k) Application Details - K150356
Device Classification Name
Enzyme Immunoassay, Benzodiazipine
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510(K) Number
K150356
Device Name
Enzyme Immunoassay, Benzodiazipine
Applicant
HEALGEN SCIENTIFIC LLC
5213 MAPLE STREET
BELLAIRE, TX 77401 US
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Contact
JIANQIU FANG
Other 510(k) Applications for this Contact
Regulation Number
862.3170
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Classification Product Code
JXM
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More FDA Info for this Product Code
Date Received
02/12/2015
Decision Date
05/13/2015
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
TX - Clinical Toxicology
Review Advisory Committee
CH - Clinical Chemistry
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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