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FDA 510(k) Application Details - K203489
Device Classification Name
Enzyme Immunoassay, Phencyclidine
More FDA Info for this Device
510(K) Number
K203489
Device Name
Enzyme Immunoassay, Phencyclidine
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
862.3100
More FDA Info for this Regulation Number
Classification Product Code
LCM
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
11/27/2020
Decision Date
04/20/2021
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
-
Review Advisory Committee
TX - Clinical Toxicology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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