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FDA 510(k) Application Details - K190968
Device Classification Name
Enzyme Immunoassay, Benzodiazipine
More FDA Info for this Device
510(K) Number
K190968
Device Name
Enzyme Immunoassay, Benzodiazipine
Applicant
Microgenics Corporation
45600 Kato Road
Fremont, CA 94538 US
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Contact
Minoti Patel
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
04/12/2019
Decision Date
12/09/2019
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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