DIASTAT ANTI-THYROGLOBULIN KIT

System, Test, Thyroid Autoantibody

SHIELD DIAGNOSTICS, LTD.

The following data is part of a premarket notification filed by Shield Diagnostics, Ltd. with the FDA for Diastat Anti-thyroglobulin Kit.

Pre-market Notification Details

Device IDK952183
510k NumberK952183
Device Name:DIASTAT ANTI-THYROGLOBULIN KIT
ClassificationSystem, Test, Thyroid Autoantibody
Applicant SHIELD DIAGNOSTICS, LTD. THE TECHNOLOGY PARK Dundee,  GB Dd2 1sw
ContactEileen A Mccafferty
CorrespondentEileen A Mccafferty
SHIELD DIAGNOSTICS, LTD. THE TECHNOLOGY PARK Dundee,  GB Dd2 1sw
Product CodeJZO  
CFR Regulation Number866.5870 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1995-05-09
Decision Date1995-06-30

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00847817016271 K952183 000
07340058410110 K952183 000

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