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FDA 510(k) Application Details - K181017
Device Classification Name
Radioimmunoassay, Testosterones And Dihydrotestosterone
More FDA Info for this Device
510(K) Number
K181017
Device Name
Radioimmunoassay, Testosterones And Dihydrotestosterone
Applicant
Monobind Inc.
100 North Pointe Drive
Lake Forest, CA 92630 US
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Contact
Anthony Shatola
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Regulation Number
862.1680
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Classification Product Code
CDZ
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More FDA Info for this Product Code
Date Received
04/10/2018
Decision Date
07/20/2018
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CH - Clinical Chemistry
Review Advisory Committee
CH - Clinical Chemistry
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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