SERAQUEST TOXOPLASMA IGG

Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii

QUEST INTL., INC.

The following data is part of a premarket notification filed by Quest Intl., Inc. with the FDA for Seraquest Toxoplasma Igg.

Pre-market Notification Details

Device IDK960092
510k NumberK960092
Device Name:SERAQUEST TOXOPLASMA IGG
ClassificationEnzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii
Applicant QUEST INTL., INC. 1938 N.E. 148TH TERR. North Miami,  FL  33181
ContactRobert A Cort
CorrespondentRobert A Cort
QUEST INTL., INC. 1938 N.E. 148TH TERR. North Miami,  FL  33181
Product CodeLGD  
CFR Regulation Number866.3780 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1996-01-11
Decision Date1996-06-17
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00811727015150 K960092 000
00816057020539 K960092 000
00847865010702 K960092 000

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.