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510(k) K925209

Device
MUMPS STAT
Applicant
BIOWHITTAKER MOLECULAR APPLICATIONS, INC.
510(k) number
K925209
Product code
LJY  
Decision
Substantially Equivalent (SESE)
Decision date
1994-10-14
Date received
1992-10-07
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
LEIF E OLSEN
Address
8830 Biggs Ford Rd. Walkersville MD US 21793 21793

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
K961204MUMPS IGG TESTZeus Scientific, Inc.1996-07-18
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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