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FDA 510(k) Application Details - K123080
Device Classification Name
Enzyme Immunoassay, Benzodiazipine
More FDA Info for this Device
510(K) Number
K123080
Device Name
Enzyme Immunoassay, Benzodiazipine
Applicant
CHEMTRON BIOTECH, INC.
8370 JUNIPER CREEK LANE
SUITE 1-2
SAN DIEGO, CA 92126 US
Other 510(k) Applications for this Company
Contact
Jane Zhang
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
10/01/2012
Decision Date
11/29/2012
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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