FIAX TEST KIT FOR MEASLES-G ANTIBODIES FLYORESCENT

Antiserum, Fluorescent, Rubeola

IDT, A DIVISION OF WHITTAKER M.A. BIOPRODUCTS

The following data is part of a premarket notification filed by Idt, A Division Of Whittaker M.a. Bioproducts with the FDA for Fiax Test Kit For Measles-g Antibodies Flyorescent.

Pre-market Notification Details

Device IDK853067
510k NumberK853067
Device Name:FIAX TEST KIT FOR MEASLES-G ANTIBODIES FLYORESCENT
ClassificationAntiserum, Fluorescent, Rubeola
Applicant IDT, A DIVISION OF WHITTAKER M.A. BIOPRODUCTS 2050 CONCOURSE DR. San Jose,  CA  95131
ContactLouise Harris
CorrespondentLouise Harris
IDT, A DIVISION OF WHITTAKER M.A. BIOPRODUCTS 2050 CONCOURSE DR. San Jose,  CA  95131
Product CodeGRE  
CFR Regulation Number866.3520 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1985-07-22
Decision Date1985-10-22

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