SERAQUEST MUMPS IGG

Enzyme Linked Immunoabsorbent Assay, Mumps Virus

QUEST INTL., INC.

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

Pre-market Notification Details

Device IDK980059
510k NumberK980059
Device Name:SERAQUEST MUMPS IGG
ClassificationEnzyme Linked Immunoabsorbent Assay, Mumps Virus
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 CodeLJY  
CFR Regulation Number866.3380 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1998-01-07
Decision Date1998-04-23

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00816057020614 K980059 000
00847865010771 K980059 000

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