I-125 LABELED DIGOXIN

Radioimmunoassay, Digoxin (125-i)

PCL-RIA, INC.

The following data is part of a premarket notification filed by Pcl-ria, Inc. with the FDA for I-125 Labeled Digoxin.

Pre-market Notification Details

Device IDK803047
510k NumberK803047
Device Name:I-125 LABELED DIGOXIN
ClassificationRadioimmunoassay, Digoxin (125-i)
Applicant PCL-RIA, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeLCS  
CFR Regulation Number862.3320 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1980-12-01
Decision Date1980-12-22

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