AGGLUTINOTEST-TOXOPLASMOSIS

Antigens, Cf, Toxoplasma Gondii

VOLU SOL MEDICAL INDUSTRIES

The following data is part of a premarket notification filed by Volu Sol Medical Industries with the FDA for Agglutinotest-toxoplasmosis.

Pre-market Notification Details

Device IDK791456
510k NumberK791456
Device Name:AGGLUTINOTEST-TOXOPLASMOSIS
ClassificationAntigens, Cf, Toxoplasma Gondii
Applicant VOLU SOL MEDICAL INDUSTRIES 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeGMN  
CFR Regulation Number866.3780 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1979-08-06
Decision Date1979-09-24

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