MAGIC 125I DIGOXIN RADIOIMMUNOASSAY

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

CORNING MEDICAL & SCIENTIFIC

The following data is part of a premarket notification filed by Corning Medical & Scientific with the FDA for Magic 125i Digoxin Radioimmunoassay.

Pre-market Notification Details

Device IDK840461
510k NumberK840461
Device Name:MAGIC 125I DIGOXIN RADIOIMMUNOASSAY
ClassificationRadioimmunoassay, Digoxin (125-i), Rabbit Antibody, Solid Phase Sep.
Applicant CORNING MEDICAL & SCIENTIFIC 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeDON  
CFR Regulation Number862.3320 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1984-02-02
Decision Date1984-03-23

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