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510(k) K980059

Device
SERAQUEST MUMPS IGG
Applicant
QUEST INTL., INC.
510(k) number
K980059
Product code
LJY  
Decision
Substantially Equivalent (SESE)
Decision date
1998-04-23
Date received
1998-01-07
Regulation
866.3380
Classification name
Enzyme Linked Immunoabsorbent Assay, Mumps Virus
Medical specialty
Microbiology
Review panel
Microbiology
Device class
1
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
ROBERT A CORT
Address
1938 NE 148th Terr. North Miami FL US 33181 33181

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code LJY  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K991274MUMPS IGG ELISA TEST SYSTEMColumbia Bioscience, Inc.1999-09-03
K971857MUMPS IGG ELISA TESTYGull Laboratories, Inc.1997-11-04
K961204MUMPS IGG TESTZeus Scientific, Inc.1996-07-18
K925209MUMPS STATBiowhittaker Molecular Applications, Inc.1994-10-14
K923903VITEK IMMUNODIAGNOSTIC ASSAY SYSTEM MUMPS IGG ASSABiomerieux Vitek, Inc.1993-08-09
K897006PHARMACIA MUMPS IGG ELISAPharmacia Eni Diagnostics, Inc.1990-07-26
K830045MUMPSELISA TEST KITM.A. Bioproducts1983-05-13

Legacy Summary#

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FDA Review#

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