SERODOT TOXOPLASMA IGG TEST KIT

Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii

DISEASE DETECTION INTERNATIONAL, INC.

The following data is part of a premarket notification filed by Disease Detection International, Inc. with the FDA for Serodot Toxoplasma Igg Test Kit.

Pre-market Notification Details

Device IDK875363
510k NumberK875363
Device Name:SERODOT TOXOPLASMA IGG TEST KIT
ClassificationEnzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii
Applicant DISEASE DETECTION INTERNATIONAL, INC. 17935 SKY PARK CIRCLE, SUITE D Irvine,  CA  92714
ContactEl-badry
CorrespondentEl-badry
DISEASE DETECTION INTERNATIONAL, INC. 17935 SKY PARK CIRCLE, SUITE D Irvine,  CA  92714
Product CodeLGD  
CFR Regulation Number866.3780 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1987-12-31
Decision Date1988-04-21

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