TOXOTEST-MT EIKEN KIT

Antigens, Iha, Toxoplasma Gondii

SYN-KIT, INC.

The following data is part of a premarket notification filed by Syn-kit, Inc. with the FDA for Toxotest-mt Eiken Kit.

Pre-market Notification Details

Device IDK802452
510k NumberK802452
Device Name:TOXOTEST-MT EIKEN KIT
ClassificationAntigens, Iha, Toxoplasma Gondii
Applicant SYN-KIT, INC. 4221 Richmond Rd., N.W. Walker,  MI  49534
Product CodeGMM  
CFR Regulation Number866.3780 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1980-10-08
Decision Date1980-12-18

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