PHASE II DIGOXIN RADIOIMMUNOASSAY KIT

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

MEDICAL & SCIENTIFIC DESIGNS, INC.

The following data is part of a premarket notification filed by Medical & Scientific Designs, Inc. with the FDA for Phase Ii Digoxin Radioimmunoassay Kit.

Pre-market Notification Details

Device IDK830533
510k NumberK830533
Device Name:PHASE II DIGOXIN RADIOIMMUNOASSAY KIT
ClassificationRadioimmunoassay, Digoxin (125-i), Rabbit Antibody, Solid Phase Sep.
Applicant MEDICAL & SCIENTIFIC DESIGNS, INC. 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 Received1983-02-18
Decision Date1983-04-05

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