IDS-iSYS Ostase BAP

Electrophoretic Separation, Alkaline Phosphatase Isoenzymes

Immunodiagnostic Systems Ltd.

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

Pre-market Notification Details

Device IDK200475
510k NumberK200475
Device Name:IDS-iSYS Ostase BAP
ClassificationElectrophoretic Separation, Alkaline Phosphatase Isoenzymes
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 CodeCIN  
CFR Regulation Number862.1050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-02-26
Decision Date2020-09-30

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