QMS / MULTIGENT VALPROIC ACID REAGENT, PART #396075

Enzyme Immunoassay, Valproic Acid

SERADYN

The following data is part of a premarket notification filed by Seradyn with the FDA for Qms / Multigent Valproic Acid Reagent, Part #396075.

Pre-market Notification Details

Device IDK030405
510k NumberK030405
Device Name:QMS / MULTIGENT VALPROIC ACID REAGENT, PART #396075
ClassificationEnzyme Immunoassay, Valproic Acid
Applicant SERADYN 7998 GEORGETOWN RD. SUITE 1000 Indianapolis,  IN  46268
ContactLes Padilla
CorrespondentLes Padilla
SERADYN 7998 GEORGETOWN RD. SUITE 1000 Indianapolis,  IN  46268
Product CodeLEG  
CFR Regulation Number862.3645 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2003-02-06
Decision Date2003-04-28
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00380740154158 K030405 000
00380740000332 K030405 000

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