125I DIGOXIN RADIOIMMUNOASSAY KIT

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

CAMBRIDGE MEDICAL TECHNOLOGY

The following data is part of a premarket notification filed by Cambridge Medical Technology with the FDA for 125i Digoxin Radioimmunoassay Kit.

Pre-market Notification Details

Device IDK821811
510k NumberK821811
Device Name:125I DIGOXIN RADIOIMMUNOASSAY KIT
ClassificationRadioimmunoassay, Digoxin (125-i), Rabbit Antibody, Charcoal Sep.
Applicant CAMBRIDGE MEDICAL TECHNOLOGY 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 Received1982-06-18
Decision Date1982-07-02

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