DIGOXIN RADIOIMMUNOASSAY

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

AMERICAN DIAGNOSTIC CORP.

The following data is part of a premarket notification filed by American Diagnostic Corp. with the FDA for Digoxin Radioimmunoassay.

Pre-market Notification Details

Device IDK820274
510k NumberK820274
Device Name:DIGOXIN RADIOIMMUNOASSAY
ClassificationRadioimmunoassay, Digoxin (125-i), Rabbit Antibody, Charcoal Sep.
Applicant AMERICAN DIAGNOSTIC CORP. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeDPB  
CFR Regulation Number862.3320 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1982-02-02
Decision Date1982-02-23

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