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510(k) K897006

Device
PHARMACIA MUMPS IGG ELISA
Applicant
PHARMACIA ENI DIAGNOSTICS, INC.
510(k) number
K897006
Product code
LJY  
Decision
Substantially Equivalent (SESE)
Decision date
1990-07-26
Date received
1989-12-18
Regulation
866.3380
Classification name
Enzyme Linked Immunoabsorbent Assay, Mumps Virus
Medical specialty
Microbiology
Review panel
Microbiology
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
KAREN DARCY
Address
8310 Guilford Rd. Suite E Columbia MD US 21046 21046

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
K925209MUMPS STATBiowhittaker Molecular Applications, Inc.1994-10-14
K923903VITEK IMMUNODIAGNOSTIC ASSAY SYSTEM MUMPS IGG ASSABiomerieux Vitek, Inc.1993-08-09
K830045MUMPSELISA TEST KITM.A. Bioproducts1983-05-13

Legacy Summary#

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FDA Review#

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