INNOFLUOR(TM) DIGITOXIN REAGENT SET

Enzyme Immunoassay, Digitoxin

INTL. BIOCLINICAL, INC.

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

Pre-market Notification Details

Device IDK913187
510k NumberK913187
Device Name:INNOFLUOR(TM) DIGITOXIN REAGENT SET
ClassificationEnzyme Immunoassay, Digitoxin
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 CodeLFM  
CFR Regulation Number862.3300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1991-07-18
Decision Date1991-09-23

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