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510(k) K914454

Device
THE THERATEST EL-ANA PROFILES
Applicant
THERATEST LABORATORIES, INC.
510(k) number
K914454
Product code
LKJ  
Decision
Substantially Equivalent (SESE)
Decision date
1992-05-22
Date received
1991-10-07
Regulation
866.5100
Classification name
Antinuclear Antibody, Antigen, Control
Medical specialty
Immunology
Review panel
Immunology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
MARIUS TEODORESCU
Address
2201 W. Campbell Park Dr. Chicago IL US 60612 60612

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code LKJ  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K210902EliA Ro52, EliA Ro60Phadia AB2022-07-27
K113610ANA-SCREEN WITH MDSSBio-Rad Laboratories2012-07-09
K082759ELIA CENP IMMUNOASSAY, ELIA U1RNP IMMUNOASSAY, ELIA SM IMMUNOASSAY, ELIA RO IMMUNOASSAYPhadia US, Inc.2009-04-10
K081104AESKULISA ANA HEP-2, REF 30-7115USAesku Diagnostics2008-05-02
K041658BIOPLEX 200 ANA SCREEN ON THE BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM, MODEL BIOPLEX 2200Bio-Rad Laboratories, Inc.2004-12-20
K042416ATHENA MULTI-LYTE ANA-II TEST SYSTEMZeus Scientific, Inc.2004-10-08
K034013REAADS DSDNA QUANTITATIVE TEST KIT, MODEL 022-001Corgenix, Inc.2004-01-08
K030775AUTO I.D. JO-1, SCL-70 & PCNA POSITIVE CONTROL SERUMImmuno Concepts, N.A. , Ltd.2003-05-12
K024218LIQUICHEK ANTI-SS-A CONTROL, POSITIVE, CATALOG #114Bio-Rad2003-01-17
K024232LIQUICHEK ANTI-SS-B CONTROL, POSITIVE, CATALOG #113Bio-Rad2003-01-17
K024223LIQUICHEK ANTI-RNP CONTROL, POSITIVE, CATALOG #116Bio-Rad2003-01-13
K024226LIQUICHEK ANTI-SCL-70 CONTROL, POSITIVE, CATALOG #116Bio-Rad2003-01-10
K021257ANA LINE BLOT, CATALOG NUMBER: KALABI (20 TESTS)Diagnostic Products Corp.2002-06-03
K021103MODIFICATION TO ZEUS SCIENTIFIC'S ATHENA MULTI-LYTE ANA TEST SYSTEMZeus Scientific, Inc.2002-04-24
K011244ZEUS SCIENTIFIC, INC. ATHENA MULTI-LYTE ANA TEST SYSTEMZeus Scientific, Inc.2001-12-10

Legacy Summary#

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FDA Review#

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