GAMMA-B 25-HYDROXY VITAMIN D RIA

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 Gamma-b 25-hydroxy Vitamin D Ria.

Pre-market Notification Details

Device IDK991998
510k NumberK991998
Device Name:GAMMA-B 25-HYDROXY VITAMIN D RIA
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)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1999-06-14
Decision Date1999-09-17

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
05060169690004 K991998 000

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