INNOFLUOR (TM) AMIKACIN REAGENT SET

Radioimmunoassay, Amikacin

INNOTRON OF OREGON, INC.

The following data is part of a premarket notification filed by Innotron Of Oregon, Inc. with the FDA for Innofluor (tm) Amikacin Reagent Set.

Pre-market Notification Details

Device IDK903100
510k NumberK903100
Device Name:INNOFLUOR (TM) AMIKACIN REAGENT SET
ClassificationRadioimmunoassay, Amikacin
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 CodeKLQ  
CFR Regulation Number862.3035 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1990-07-13
Decision Date1990-08-09

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