125I DIGOXIN TEST SET

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

WIEN LABORATORIES, INC.

The following data is part of a premarket notification filed by Wien Laboratories, Inc. with the FDA for 125i Digoxin Test Set.

Pre-market Notification Details

Device IDK772306
510k NumberK772306
Device Name:125I DIGOXIN TEST SET
ClassificationRadioimmunoassay, Digoxin (125-i), Rabbit Antibody, Charcoal Sep.
Applicant WIEN LABORATORIES, 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 Received1977-12-15
Decision Date1977-12-22

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.