1,25-DIHYDROXY VITAMIN D EIA

System, Test, Vitamin D

IMMUNODIAGNOSTIC SYSTEMS LTD.

The following data is part of a premarket notification filed by Immunodiagnostic Systems Ltd. with the FDA for 1,25-dihydroxy Vitamin D Eia.

Pre-market Notification Details

Device IDK051110
510k NumberK051110
Device Name:1,25-DIHYDROXY VITAMIN D EIA
ClassificationSystem, Test, Vitamin D
Applicant IMMUNODIAGNOSTIC SYSTEMS LTD. 10 DIDCOT WAY, BOLDEN BUSINESS PARK Boldon, Tyne & Wear,  GB Ne35 9pd
ContactPaul Puntin
CorrespondentPaul Puntin
IMMUNODIAGNOSTIC SYSTEMS LTD. 10 DIDCOT WAY, BOLDEN BUSINESS PARK Boldon, Tyne & Wear,  GB Ne35 9pd
Product CodeMRG  
CFR Regulation Number862.1825 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeAbbreviated
3rd Party ReviewedNo
Combination ProductNo
Date Received2005-05-02
Decision Date2005-07-06

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
05060169690097 K051110 000

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