KIT, RIA, GENTAMICIN SULF.

Radioimmunoassay, Gentamicin (125-i), Second Antibody Sep.

NEW ENGLAND NUCLEAR

The following data is part of a premarket notification filed by New England Nuclear with the FDA for Kit, Ria, Gentamicin Sulf..

Pre-market Notification Details

Device IDK760068
510k NumberK760068
Device Name:KIT, RIA, GENTAMICIN SULF.
ClassificationRadioimmunoassay, Gentamicin (125-i), Second Antibody Sep.
Applicant NEW ENGLAND NUCLEAR 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeDJB  
CFR Regulation Number862.3450 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1976-06-16
Decision Date1976-07-20

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