FIAX TOXO-M ANTIBODIES TEST KIT

Antigens, If, Toxoplasma Gondii

INTL. DIAGNOSTIC TECHNOLOGY

The following data is part of a premarket notification filed by Intl. Diagnostic Technology with the FDA for Fiax Toxo-m Antibodies Test Kit.

Pre-market Notification Details

Device IDK850591
510k NumberK850591
Device Name:FIAX TOXO-M ANTIBODIES TEST KIT
ClassificationAntigens, If, Toxoplasma Gondii
Applicant INTL. DIAGNOSTIC TECHNOLOGY 2050 CONCOURSE DR. San Jose,  CA  95131
ContactDuff Self
CorrespondentDuff Self
INTL. DIAGNOSTIC TECHNOLOGY 2050 CONCOURSE DR. San Jose,  CA  95131
Product CodeGLZ  
CFR Regulation Number866.3780 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1985-02-14
Decision Date1985-04-30

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