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510(k) K983420

Device
THE APTUS(AUTOMATED)APPLICATION OF THE SM ELISA TEST SYSTEM.AN ENZYME LINK IMMUNOSORBENT ASSAY(ELISA)FOR THE DETECTIOO
Applicant
ZEUS SCIENTIFIC, INC.
510(k) number
K983420
Product code
LKP  
Decision
Substantially Equivalent (SESE)
Decision date
1998-11-18
Date received
1998-09-29
Regulation
866.5100
Classification name
Anti-sm Antibody, Antigen And Control
Medical specialty
Immunology
Review panel
Immunology
Device class
2
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
MARK J KOPNITSKY
Address
200 Evans Way Branchburg NJ US 08876 08876

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code LKP  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K202067EliA SmDP-SPhadia AB2021-07-14
K183007EliA SmDP ImmunoassayPhadia AB2018-12-24
K132631EIA SMDP IMMUNOASSAYPhadia US, Inc.2014-08-29
K123593QUANTA FLASH SM, QUANTA FLASH RNP, QUANTA FLASH SM CALIBRATORS, QUANTA FLASH RNP CALIBRATORS, QUANTA FLASH SM CONTROLS,Inova Diagnostics, Inc.2013-04-17
K051066THERATEST EL-ANA PROFILESTheratest Laboratories, Inc.2005-10-07
K042629VARELISA SM ANTIBODIES, MODEL 18296Sweden Diagnostics (Germany) GmbH2004-12-08
K024219LIQUICHEK ANTI-SM CONTROL, POSITIVE, CATALOG #115Bio-Rad2003-01-15
K013263FRED HUTCHINSON CANCER RESEARCH CENTER ENZYME ANTI-SR PROTEIN ANTIBODY TESTFred Hutchinson Cancer Research Center2002-07-29
K000755RHIGENE MESACUP2 TEST- SMRhigene, Inc.2000-05-09
K000312VARELISA SM ANTIBODIESPharmacia & Upjohn Co.2000-03-17
K990625AUTOSTAT II ANTI-SM ELISACogent Diagnotics , Ltd.1999-04-28
K984479LIQUICHEK ANTI-SM CONTROL, EIA, MODEL 208Bio-Rad1998-12-22
K980540SERAQUEST ANTI-SMQuest Intl., Inc.1998-06-15
K980811SERAQUEST ANTI-SM/RNPQuest Intl., Inc.1998-05-12
K954830ORGENTEC ANTI-SM(SMITH) PIN IMMUNO ASSAYOrgentec1996-05-08

Legacy Summary#

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FDA Review#

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