DIGOCTK 125

Radioimmunoassay, Digoxin (125-i)

SORIN BIOMEDICA, FIAT, USA, INC.

The following data is part of a premarket notification filed by Sorin Biomedica, Fiat, Usa, Inc. with the FDA for Digoctk 125.

Pre-market Notification Details

Device IDK800773
510k NumberK800773
Device Name:DIGOCTK 125
ClassificationRadioimmunoassay, Digoxin (125-i)
Applicant SORIN BIOMEDICA, FIAT, USA, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeLCS  
CFR Regulation Number862.3320 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1980-04-07
Decision Date1980-04-24

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