LIAISON TESTOSTERONE; LIAISON TESTOSTERONE CONTROL SET

Radioimmunoassay, Testosterones And Dihydrotestosterone

DIASORIN, INC.

The following data is part of a premarket notification filed by Diasorin, Inc. with the FDA for Liaison Testosterone; Liaison Testosterone Control Set.

Pre-market Notification Details

Device IDK122793
510k NumberK122793
Device Name:LIAISON TESTOSTERONE; LIAISON TESTOSTERONE CONTROL SET
ClassificationRadioimmunoassay, Testosterones And Dihydrotestosterone
Applicant DIASORIN, INC. 1951 NORTHWESTERN AVE. Stillwater,  MN  55082 -0285
ContactJohn Eskdale
CorrespondentJohn Eskdale
DIASORIN, INC. 1951 NORTHWESTERN AVE. Stillwater,  MN  55082 -0285
Product CodeCDZ  
CFR Regulation Number862.1680 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2012-09-12
Decision Date2013-01-25
Summary:summary

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