SERADYN QMS TOPIRAMATE

Immunoassay, Anti-seizure Drug

SERADYN INC.

The following data is part of a premarket notification filed by Seradyn Inc. with the FDA for Seradyn Qms Topiramate.

Pre-market Notification Details

Device IDK070645
510k NumberK070645
Device Name:SERADYN QMS TOPIRAMATE
ClassificationImmunoassay, Anti-seizure Drug
Applicant SERADYN INC. 7998 GEORGETOWN RD. SUITE 1000 Indianapolis,  IN  46268
ContactJack Rogers
CorrespondentJack Rogers
SERADYN INC. 7998 GEORGETOWN RD. SUITE 1000 Indianapolis,  IN  46268
Product CodeNWM  
CFR Regulation Number862.3350 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2007-03-08
Decision Date2007-05-17
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00884883012707 K070645 000
00884883011298 K070645 000
00884883011250 K070645 000
00884883011175 K070645 000

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