INNOFLUOR(TM) DIGITOXIN CALIBRATOR SET

Calibrators, Drug Specific

INTL. BIOCLINICAL, INC.

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

Pre-market Notification Details

Device IDK913186
510k NumberK913186
Device Name:INNOFLUOR(TM) DIGITOXIN CALIBRATOR SET
ClassificationCalibrators, Drug Specific
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 CodeDLJ  
CFR Regulation Number862.3200 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1991-07-18
Decision Date1991-08-30

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