MODIFIED ACCUFLUOR GENTAMICIN REAGENT & CALIBRATOR

Enzyme Immunoassay, Gentamicin

INNOTRON OF OREGON, INC.

The following data is part of a premarket notification filed by Innotron Of Oregon, Inc. with the FDA for Modified Accufluor Gentamicin Reagent & Calibrator.

Pre-market Notification Details

Device IDK900703
510k NumberK900703
Device Name:MODIFIED ACCUFLUOR GENTAMICIN REAGENT & CALIBRATOR
ClassificationEnzyme Immunoassay, Gentamicin
Applicant INNOTRON OF OREGON, INC. 4432 SE 16TH AVE. Portland,  OR  97202
ContactCraig Smart
CorrespondentCraig Smart
INNOTRON OF OREGON, INC. 4432 SE 16TH AVE. Portland,  OR  97202
Product CodeLCD  
CFR Regulation Number862.3450 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1990-02-12
Decision Date1990-04-12

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