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510(k) K895468

Device
ORGENICS IMMUNOCOMB(TM) CHLAMYDIA TRACHOMATIS IGG
Applicant
ORGENICS LTD.
510(k) number
K895468
Product code
LJC  
Decision
Substantially Equivalent (SESE)
Decision date
1990-03-13
Date received
1989-09-11
Regulation
866.3120
Classification name
Enzyme Linked Immunoabsorbent Assay, (chlamydiae Group)
Medical specialty
Microbiology
Review panel
Microbiology
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
CONSTANCE DUCAR
Address
P.O. Box 2443 Columbia MD US 21043 21043

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code LJC  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K032330CT OIAThermo Biostar, Inc.2004-03-02
K033865IDEIA PCE CHLAMYDIADakocytomation, Ltd.2004-01-21
K033079CHLAMYDIA IGG ELISA TEST SYSTEMTrinity Biotech USA2003-11-26
K982210MODIFICATION OF SYVA MICROTRAK II CHLAMYDIA EIADade Behring, Inc.1998-07-09
K962558CHLAMYDIA IGG ELISA TEST SYSTEMArmkel, LLC1997-02-24
K960850ACCESS CHLAMYDIA ASSAYBio-Rad Laboratories, Inc.1997-02-04
K955627VIDAS CHLAMYDIA BLOCKING ASSAYBiomerieux Vitek, Inc.1996-10-07
K936054IMX SELECT CHLAMYDIAAbbott Laboratories1996-05-30
K940564IDEIA(TM) CHLAMYDIA BLOCKING REAGENTS, MODIFICATIONDako Diagnostics , Ltd.1996-01-11
K951010CHLAMYDIA OIABiostar, Inc.1995-10-07
K946276QUICKVUE(R) CHLAMYDIA TESTQuidel Corp.1995-05-19
K935807ACCESS(R) CHLAMYDIA EIA AND BLOCKING ASSAYBio-Rad Laboratories, Inc.1995-05-19
K935393CHLAMYDIA MICROPLATE EIA, CHLAMYDIA MICROPLAE EIA BLOCKING ASSAYBio-Rad Laboratories, Inc.1994-09-20
K926090SYVA MICROTRAK(R) II CHLAMYDIA EIA BLOCK REAGENTSyva Co.1993-09-30
K921747MICRO TRAK XL SYSTEMSyva Co.1992-10-01

Legacy Summary#

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FDA Review#

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