KENAMYCIN FLUORESCENT IMMUNOASSAY FIA

Radioimmunoassay, Kanamycin

AMERICAN DIAGNOSTIC CORP.

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

Pre-market Notification Details

Device IDK823062
510k NumberK823062
Device Name:KENAMYCIN FLUORESCENT IMMUNOASSAY FIA
ClassificationRadioimmunoassay, Kanamycin
Applicant AMERICAN DIAGNOSTIC CORP. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeKJI  
CFR Regulation Number862.3520 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1982-10-18
Decision Date1982-11-10

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