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FDA 510(k) Application Details - K163704
Device Classification Name
Enzyme Immunoassay, Benzodiazipine
More FDA Info for this Device
510(K) Number
K163704
Device Name
Enzyme Immunoassay, Benzodiazipine
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
862.3170
More FDA Info for this Regulation Number
Classification Product Code
JXM
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
12/29/2016
Decision Date
08/02/2017
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
TX - Clinical Toxicology
Review Advisory Committee
TX - Clinical Toxicology
Statement / Summary / Purged Status
Type
Special
Reviewed By Third Party
N
Expedited Review
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