FDA.reportPublic FDA data

510(k) K123593

Device
QUANTA FLASH SM, QUANTA FLASH RNP, QUANTA FLASH SM CALIBRATORS, QUANTA FLASH RNP CALIBRATORS, QUANTA FLASH SM CONTROLS,
Applicant
INOVA DIAGNOSTICS, INC.
510(k) number
K123593
Product code
LKP  
Decision
Substantially Equivalent (SESE)
Decision date
2013-04-17
Date received
2012-11-21
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
Summary
Third party reviewed
No

Applicant Contact#

Contact
GABRIELLA LAKOS
Address
9900 Old Grove Rd. San Diego CA US 92131 92131

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

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
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
K983420THE APTUS(AUTOMATED)APPLICATION OF THE SM ELISA TEST SYSTEM.AN ENZYME LINK IMMUNOSORBENT ASSAY(ELISA)FOR THE DETECTIOOZeus Scientific, Inc.1998-11-18
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#

summary

FDA Review#

Decision Summary