TIPSEP DIGOXIN RIA

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

NUCLEAR DIAGNOSTICS, INC.

The following data is part of a premarket notification filed by Nuclear Diagnostics, Inc. with the FDA for Tipsep Digoxin Ria.

Pre-market Notification Details

Device IDK852291
510k NumberK852291
Device Name:TIPSEP DIGOXIN RIA
ClassificationRadioimmunoassay, Digoxin (125-i), Rabbit Antibody, Second Antibody Sep.
Applicant NUCLEAR DIAGNOSTICS, INC. 575 ROBBINS DR. Troy,  MI  48083
ContactSmart, Ph.d
CorrespondentSmart, Ph.d
NUCLEAR DIAGNOSTICS, INC. 575 ROBBINS DR. Troy,  MI  48083
Product CodeDNL  
CFR Regulation Number862.3320 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1985-05-29
Decision Date1985-06-25

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