CALCITONIN KIT MITSUBISHI YUKA

Radioimmunoassay, Calcitonin

MITSUBISHI YUKA AMERICA, INC.

The following data is part of a premarket notification filed by Mitsubishi Yuka America, Inc. with the FDA for Calcitonin Kit Mitsubishi Yuka.

Pre-market Notification Details

Device IDK912536
510k NumberK912536
Device Name:CALCITONIN KIT MITSUBISHI YUKA
ClassificationRadioimmunoassay, Calcitonin
Applicant MITSUBISHI YUKA AMERICA, INC. 1625 K ST. N.W. SUITE 1000 Washington,  DC  20006
ContactMichael G Farrow
CorrespondentMichael G Farrow
MITSUBISHI YUKA AMERICA, INC. 1625 K ST. N.W. SUITE 1000 Washington,  DC  20006
Product CodeJKR  
CFR Regulation Number862.1140 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1991-06-07
Decision Date1991-07-18

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.