FDA.reportPublic FDA data

510(k) K213403

Device
Aptiva CTD Essential Reagent
Applicant
Inova Diagnostics, Inc.
510(k) number
K213403
Product code
LLL
Decision
Substantially Equivalent (SESE)
Decision date
2023-09-29
Date received
2021-10-18
Regulation
866.5100
Classification name
Extractable Antinuclear 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
Andrea Seaman
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 LLL#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
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K250408Alegria Flash ENA ScreenZeus Scientific2025-09-19
K190710EliA SymphonyS ImmunoassayPhadia AB2019-11-29
K180975QUANTA Flash HMGCR ReagentsInova Diagnostics, Inc.2018-06-25
K152635QUANTA Flash Scl-70, QUANTA Flash Scl-70 Calibrators, QUANTA Flash Scl-70 ControlsInova Diagnostics, Inc.2016-06-01
K151429QUANTA Flash Jo-1, QUANTA Flash Jo-1 Calibrators, and QUANTA Flash Jo-1 CiontrolsInova Diagnostics, Inc.2016-02-12
K142781ImmuLisa Enhanced SS-A (Ro) Antibody ELISA, ImmuLisa Enhanced SS-B (La) Antibody ELISA, ImmuLisa Enhanced Sm Antibody ELISA, ImmuLisa Enhanced RNP Antibody ELISAImmco Diagnostics, Inc.2015-03-31
K141328QUANTA FLASH RO60, QUANTA FLASH RO60 CALIBRATORS, QUANTA FLASH RO60 CONTROLSInova Diagnostics, Inc.2015-02-12
K141210QUANTA FLASH SS-B, QUANTA FLASH SS-B CALIBRATORS, AND QUANTA FLASH SS-B CONTROLSInova Diagnostics, Inc.2015-01-29
K122923QUANTA FLASH ENA7Inova Diagnostics, Inc.2013-05-07
K112996EUROIMMUN ANTI-ENA POOL ELISA (IGG)Euroimmun US2013-04-09
K113143IMMULISA SCI-70 ANTIBODY ELISAImmco Diagnostics, Inc.2011-12-02
K102607FIDISTM CONNECTIVE 10, FIDISTM ANALYZER, CARISBiomedical Diagnostics (Bmd) SA2010-12-03
K072149ELIA SYMPHONY IMMUNOASSAY, ANA CONTROL, MODEL 14-55508-01,83-1004-01Phadia US, Inc.2008-01-15
K053653FIDIS CONNECTIVE 10, MODEL MX006Biomedical Diagnostics (Bmd) SA2006-03-13