AMIKACIN FLUORESCENT IMMUNOASSAY

Radioimmunoassay, Amikacin

AMERICAN DIAGNOSTIC CORP.

The following data is part of a premarket notification filed by American Diagnostic Corp. with the FDA for Amikacin Fluorescent Immunoassay.

Pre-market Notification Details

Device IDK813541
510k NumberK813541
Device Name:AMIKACIN FLUORESCENT IMMUNOASSAY
ClassificationRadioimmunoassay, Amikacin
Applicant AMERICAN DIAGNOSTIC CORP. 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 Received1981-12-21
Decision Date1982-01-12

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