STRATUS AMIKACIN FLUOROMETRIC

Radioimmunoassay, Amikacin

AMERICAN DADE

The following data is part of a premarket notification filed by American Dade with the FDA for Stratus Amikacin Fluorometric.

Pre-market Notification Details

Device IDK832336
510k NumberK832336
Device Name:STRATUS AMIKACIN FLUOROMETRIC
ClassificationRadioimmunoassay, Amikacin
Applicant AMERICAN DADE 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeKLQ  
CFR Regulation Number862.3035 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1983-07-18
Decision Date1983-08-31

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