BRAHMS DIAGNOSTICA DYNOTEST ANTI-TG

System, Test, Thyroid Autoantibody

BRAHMS DIAGNOSTICA, LLC.

The following data is part of a premarket notification filed by Brahms Diagnostica, Llc. with the FDA for Brahms Diagnostica Dynotest Anti-tg.

Pre-market Notification Details

Device IDK992790
510k NumberK992790
Device Name:BRAHMS DIAGNOSTICA DYNOTEST ANTI-TG
ClassificationSystem, Test, Thyroid Autoantibody
Applicant BRAHMS DIAGNOSTICA, LLC. 29 SOUTH PEACHTREE ST. Norcross,  GA  30071
ContactH. Lee Herron
CorrespondentH. Lee Herron
BRAHMS DIAGNOSTICA, LLC. 29 SOUTH PEACHTREE ST. Norcross,  GA  30071
Product CodeJZO  
CFR Regulation Number866.5870 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1999-08-19
Decision Date1999-11-12
Summary:summary

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