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FDA 510(k) Application Details - K203564
Device Classification Name
Enzyme Immunoassay, Opiates
More FDA Info for this Device
510(K) Number
K203564
Device Name
Enzyme Immunoassay, Opiates
Applicant
Immunalysis Corporation
829 Towne Center Drive
Pomona, CA 91767 US
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Contact
Wenying (Jessica) Zhu
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
12/07/2020
Decision Date
12/22/2021
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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