FIAX TEST KIT FOR ANTI-TOXOPLASMA ANTIBO

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 Test Kit For Anti-toxoplasma Antibo.

Pre-market Notification Details

Device IDK790464
510k NumberK790464
Device Name:FIAX TEST KIT FOR ANTI-TOXOPLASMA ANTIBO
ClassificationAntigens, If, Toxoplasma Gondii
Applicant INTL. DIAGNOSTIC TECHNOLOGY 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeGLZ  
CFR Regulation Number866.3780 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1979-03-05
Decision Date1979-06-13

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