RIA COAT DIGOXIN

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

IMMUNO ASSAY CORP.

The following data is part of a premarket notification filed by Immuno Assay Corp. with the FDA for Ria Coat Digoxin.

Pre-market Notification Details

Device IDK833842
510k NumberK833842
Device Name:RIA COAT DIGOXIN
ClassificationRadioimmunoassay, Digoxin (125-i), Rabbit Antibody, Coated Tube Sep.
Applicant IMMUNO ASSAY CORP. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeDPO  
CFR Regulation Number862.3320 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1983-11-03
Decision Date1984-01-17

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