ANTI-TOXOPLASMA GONDII KIT

Antigens, If, Toxoplasma Gondii

AMICO LAB, INC.

The following data is part of a premarket notification filed by Amico Lab, Inc. with the FDA for Anti-toxoplasma Gondii Kit.

Pre-market Notification Details

Device IDK842664
510k NumberK842664
Device Name:ANTI-TOXOPLASMA GONDII KIT
ClassificationAntigens, If, Toxoplasma Gondii
Applicant AMICO LAB, INC. 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 Received1984-07-10
Decision Date1984-08-28

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