BIOTROL TOXO ELISA TEST M

Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii

BIOTROL, USA, INC.

The following data is part of a premarket notification filed by Biotrol, Usa, Inc. with the FDA for Biotrol Toxo Elisa Test M.

Pre-market Notification Details

Device IDK873293
510k NumberK873293
Device Name:BIOTROL TOXO ELISA TEST M
ClassificationEnzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii
Applicant BIOTROL, USA, INC. 5 GREAT VALLEY PKWY, SUITE 248 GREAT VALLEY CORP. CENTER Malvern,  PA  19355
ContactAllan C Murphy
CorrespondentAllan C Murphy
BIOTROL, USA, INC. 5 GREAT VALLEY PKWY, SUITE 248 GREAT VALLEY CORP. CENTER Malvern,  PA  19355
Product CodeLGD  
CFR Regulation Number866.3780 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1987-08-17
Decision Date1988-04-12

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