IDS SHBG

Radioimmunoassay, Testosterones And Dihydrotestosterone

Immunodiagnostic Systems Ltd.

The following data is part of a premarket notification filed by Immunodiagnostic Systems Ltd. with the FDA for Ids Shbg.

Pre-market Notification Details

Device IDK190121
510k NumberK190121
Device Name:IDS SHBG
ClassificationRadioimmunoassay, Testosterones And Dihydrotestosterone
Applicant Immunodiagnostic Systems Ltd. 10 Didcot Way Boldon Business Park Boldon,  GB Ne35 9pd
ContactMick Henderson
CorrespondentMick Henderson
Immunodiagnostic Systems Ltd. 10 Didcot Way Boldon Business Park Boldon,  GB Ne35 9pd
Product CodeCDZ  
CFR Regulation Number862.1680 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-01-25
Decision Date2019-06-17

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
05060169691322 K190121 000

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