TOXO BIO-BEAD SCREEN KIT

Antigens, If, Toxoplasma Gondii

LITTON BIONETICS

The following data is part of a premarket notification filed by Litton Bionetics with the FDA for Toxo Bio-bead Screen Kit.

Pre-market Notification Details

Device IDK791611
510k NumberK791611
Device Name:TOXO BIO-BEAD SCREEN KIT
ClassificationAntigens, If, Toxoplasma Gondii
Applicant LITTON BIONETICS 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 Received1979-08-21
Decision Date1979-11-13

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