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510(k) K820643

Device
Ortho Spectrum Iii & Ortho-mune Ok
Applicant
ORTHO DIAGNOSTIC SYSTEMS, INC.
510(k) number
K820643
Product code
LIZ
Decision
Substantially Equivalent (SESE)
Decision date
1982-07-14
Date received
1982-03-08
Regulation
864.5220
Classification name
Assay, T Lymphocyte Surface Marker
Medical specialty
Hematology
Review panel
Hematology
Device class
2
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Address
125 Mark Ave. Carpinteria CA US 93013 93013

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code LIZ#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K914847CD8 MONOCLONAL ANTIBODIESGen Trak, Inc.1992-06-19
K860830TECHNICON H.1 SYSTEM, T LYMPHOCYTES METHODTechnicon Instruments Corp.1986-09-08
K843062TBM-REAGENT FOR T,B CELL & MONOCYTESBd Becton Dickinson Vacutainer Systems Preanalytic1985-04-03
K842218ANTI-LEU-4 FITC LYSIN C BUFFERBd Becton Dickinson Vacutainer Systems Preanalytic1984-12-27
K833929WHITE BLOOD CELLS HUMAN TAND BControl Diagnostics1984-02-03
K831053QUANTIGEN T & B CELL ASSAYBio-Rad1983-08-08