INNOFLUOR(TM) VALPROIC ACID REAGENT SET

Enzyme Immunoassay, Valproic Acid

INTL. BIOCLINICAL, INC.

The following data is part of a premarket notification filed by Intl. Bioclinical, Inc. with the FDA for Innofluor(tm) Valproic Acid Reagent Set.

Pre-market Notification Details

Device IDK911688
510k NumberK911688
Device Name:INNOFLUOR(TM) VALPROIC ACID REAGENT SET
ClassificationEnzyme Immunoassay, Valproic Acid
Applicant INTL. BIOCLINICAL, INC. 6040 N. CUTTER CIRCLE SUITE 317 Portland,  OR  97217
ContactCraig Smart
CorrespondentCraig Smart
INTL. BIOCLINICAL, INC. 6040 N. CUTTER CIRCLE SUITE 317 Portland,  OR  97217
Product CodeLEG  
CFR Regulation Number862.3645 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1991-04-16
Decision Date1991-07-05

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