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510(k) K955794

Device
IGA IMMUNOTURBIDIMETRIC & CALIBRATOR
Applicant
RANDOX LABORATORIES, LTD.
510(k) number
K955794
Product code
CZP  
Decision
Substantially Equivalent (SESE)
Decision date
1996-04-05
Date received
1995-12-22
Regulation
866.5510
Classification name
Iga, Antigen, Antiserum, Control
Medical specialty
Immunology
Review panel
Immunology
Device class
2
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
JULIUE TAYLOR
Address
Ardmore, Diamond Rd. Crumlin IE BT29 4QY BT29 4QY

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code CZP  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K193525Yumizen C1200 Immunoglobulin A, Yumizen C1200 Immunoglobulin G, Yumizen C1200 Immunoglobulin MHORIBA ABX SAS2020-06-26
K060130IMMAGE SYSTEMS LOW CONCENTRATION IMMUNOGLOBULIN A REAGENTBeckman Coulter, Inc.2006-02-13
K040435ROCHE DIAGNOSTICS TINA-QUANT IGA GEN.2Roche Diagnostics Corp.2004-03-10
K024038N LATEX IGADade Behring, Inc.2003-02-13
K993927WAKO IGA II-HA, IMMUNOGLOBULIN CALIBRATOR SET, IMMUNOGLOBULIN STANDRADWako Chemicals USA, Inc.2000-01-14
K983359IGAAbbott Laboratories1998-11-04
K962200QUANTEX IGAInstrumentation Laboratory CO1996-09-25
K955907BOEHRINGER MANNHEIM IGA ASSAYBoehringer Mannheim Corp.1996-02-09
K952309N LATEX IGABehring Diagnostics, Inc.1995-06-20
K931806IGA SUBCLASS RID KIT FOR DIAGNOSTIC USEThe Binding Site, Ltd.1993-07-16
K920014IL TEST IMMUNOGLOBULIN AInstrumentation Laboratory CO1992-06-16
K900422TITAN GEL IMMUNOFIX KIT, CAT. NO. 3046Helena Laboratories1990-02-27
K894418RAICHEM(TM) SPIA(TM) IGA REAGENTSReagents Applications, Inc.1989-08-02
K890560SPQ(TM) ANTIBODY REAGENT SET II FOR IGAAtlantic Antibodies1989-02-15
K884040IMMUNOCHEMICAL DETERMINATION OF IMMUNOGLOBULIN AOrion Diagnostica, Inc.1988-10-19

Legacy Summary#

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FDA Review#

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