DIGOXIN KIT

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

PCL-RIA, INC.

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

Pre-market Notification Details

Device IDK823014
510k NumberK823014
Device Name:DIGOXIN KIT
ClassificationRadioimmunoassay, Digoxin (125-i), Rabbit Antibody, Charcoal Sep.
Applicant PCL-RIA, INC. 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 Received1982-10-13
Decision Date1982-11-01

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