SPAC DIGOXIN KIT

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

MALLINCKRODT CRITICAL CARE

The following data is part of a premarket notification filed by Mallinckrodt Critical Care with the FDA for Spac Digoxin Kit.

Pre-market Notification Details

Device IDK760800
510k NumberK760800
Device Name:SPAC DIGOXIN KIT
ClassificationRadioimmunoassay, Digoxin (125-i), Rabbit Antibody, Solid Phase Sep.
Applicant MALLINCKRODT CRITICAL CARE 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 Received1976-10-08
Decision Date1976-11-01

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