RIANEN ASSAY SYSTEM, 125I KIT

Radioimmunoassay, Digoxin (125-i), Rabbit Antibody, Second Antibody Sep.

NEW ENGLAND NUCLEAR

The following data is part of a premarket notification filed by New England Nuclear with the FDA for Rianen Assay System, 125i Kit.

Pre-market Notification Details

Device IDK781495
510k NumberK781495
Device Name:RIANEN ASSAY SYSTEM, 125I KIT
ClassificationRadioimmunoassay, Digoxin (125-i), Rabbit Antibody, Second Antibody Sep.
Applicant NEW ENGLAND NUCLEAR 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeDNL  
CFR Regulation Number862.3320 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1978-08-30
Decision Date1978-09-14

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