CIBA CORNING MAGIC LITE DIGOXIN IMMUNOASSAY

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

CIBA CORNING DIAGNOSTICS CORP.

The following data is part of a premarket notification filed by Ciba Corning Diagnostics Corp. with the FDA for Ciba Corning Magic Lite Digoxin Immunoassay.

Pre-market Notification Details

Device IDK881679
510k NumberK881679
Device Name:CIBA CORNING MAGIC LITE DIGOXIN IMMUNOASSAY
ClassificationRadioimmunoassay, Digoxin (125-i), Rabbit Antibody, Solid Phase Sep.
Applicant CIBA CORNING DIAGNOSTICS CORP. 333 CONEY ST. E. Walpole,  MA  02032
ContactWilliam J Pignato
CorrespondentWilliam J Pignato
CIBA CORNING DIAGNOSTICS CORP. 333 CONEY ST. E. Walpole,  MA  02032
Product CodeDON  
CFR Regulation Number862.3320 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1988-04-19
Decision Date1988-07-08

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