AGGLUTINOTEST-INFECTIOUS MONONUCLEOSIS

System, Test, Infectious Mononucleosis

VOLU SOL MEDICAL INDUSTRIES

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

Pre-market Notification Details

Device IDK791455
510k NumberK791455
Device Name:AGGLUTINOTEST-INFECTIOUS MONONUCLEOSIS
ClassificationSystem, Test, Infectious Mononucleosis
Applicant VOLU SOL MEDICAL INDUSTRIES 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeKTN  
CFR Regulation Number866.5640 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1979-08-06
Decision Date1979-12-31

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