BRAHMS DIAGNOSTICA DYNOTEST TG-PLUS

System, Test, Thyroglobulin

BRAHMS DIAGNOSTICA, LLC.

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

Pre-market Notification Details

Device IDK021057
510k NumberK021057
Device Name:BRAHMS DIAGNOSTICA DYNOTEST TG-PLUS
ClassificationSystem, Test, Thyroglobulin
Applicant BRAHMS DIAGNOSTICA, LLC. 35 B SOUTH PEACHTREE ST. Norcross,  GA  30071
ContactWilliam G Frank
CorrespondentWilliam G Frank
BRAHMS DIAGNOSTICA, LLC. 35 B SOUTH PEACHTREE ST. Norcross,  GA  30071
Product CodeMSW  
CFR Regulation Number866.6010 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2002-04-01
Decision Date2002-09-17
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
04260157631106 K021057 000

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