BRAHMS DIAGNOSTICA LUMITEST ANTI-TPO

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 Lumitest Anti-tpo.

Pre-market Notification Details

Device IDK000287
510k NumberK000287
Device Name:BRAHMS DIAGNOSTICA LUMITEST ANTI-TPO
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 Received2000-01-31
Decision Date2000-03-17

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