DAC-CEL DIGOXIN RADIOIMMUNOASSAY KIT

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

BURROUGHS WELLCOME CO.

The following data is part of a premarket notification filed by Burroughs Wellcome Co. with the FDA for Dac-cel Digoxin Radioimmunoassay Kit.

Pre-market Notification Details

Device IDK780475
510k NumberK780475
Device Name:DAC-CEL DIGOXIN RADIOIMMUNOASSAY KIT
ClassificationRadioimmunoassay, Digoxin (125-i), Rabbit Antibody, Solid Phase Sep.
Applicant BURROUGHS WELLCOME CO. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeDON  
CFR Regulation Number862.3320 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1978-03-24
Decision Date1978-04-24

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