FDA.reportPublic FDA data

510(k) K961204

Device
MUMPS IGG TEST
Applicant
ZEUS SCIENTIFIC, INC.
510(k) number
K961204
Product code
LJY  
Decision
Substantially Equivalent (SESE)
Decision date
1996-07-18
Date received
1996-03-27
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
MARK J KOPNITSKY
Address
P.O.Box 38 Raritan NJ US 08869 08869

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
K980059SERAQUEST MUMPS IGGQuest Intl., Inc.1998-04-23
K971857MUMPS IGG ELISA TESTYGull Laboratories, Inc.1997-11-04
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#

Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases

FDA Review#

Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases