Medical Device Manufacturer · US , San Diego , CA

Inova Diagnostics, Inc.

138 submissions · 136 cleared · Since 1988
138
Total
136
Cleared
2
Denied

Inova Diagnostics, Inc. — FDA 510(k) Submissions

Inova Diagnostics, Inc. has submitted 138 FDA 510(k) premarket notifications since 1988, of which 136 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Extractable Antinuclear Antibody, Antigen And Control, Autoantibodies, Endomysial(tissue Transglutaminase), System, Test, Anticardiolipin Immunological, Test System, Antineutrophil Cytoplasmic Antibodies (anca), Antibodies, Gliadin . Use the specialty filter in the sidebar to narrow results.

138 devices
1–25 of 138
Aptiva APS IgA Reagent
K243979 · MSV System,test,antibodies,b2... · Immunology
Feb 2026 410d
Aptiva APS IgG Reagent; Aptiva APS IgM Reagent
K223093 · MID System, Test,... · Immunology
Dec 2024 809d
Aptiva CTD Essential Reagent
K213403 · LLL Extractable Antinuclear... · Immunology
Sep 2023 711d
Aptiva Celiac Disease IgG Reagent
K200230 · MVM Autoantibodies,... · Immunology
Aug 2021 574d
Aptiva Celiac Disease IgA Reagent
K193604 · MVM Autoantibodies,... · Immunology
Jun 2021 541d
NOVA Lite DAPI dsDNA Crithidia luciliae Kit
K192916 · KTL Anti-dna Indirect... · Immunology
Dec 2020 423d
QUANTA Flash RF IgM Reagents, QUANTA Flash RF IgA Reagents
K190088 · DHR System, Test, Rheumatoid... · Immunology
Apr 2019 90d
QUANTA Flash Calprotectin and Fecal Extraction Device
K180971 · NXO Calprotectin, Fecal · Immunology
Oct 2018 186d
QUANTA Flash HMGCR Reagents
K180975 · LLL Extractable Antinuclear... · Immunology
Jun 2018 73d
QUANTA Flash Calprotectin Reagents, QUANTA Flash Calprotectin Calibrators, QUANTA Flash Calprotectin Controls, QUANTA Flash Calprotectin Extraction Buffer
K170993 · NXO Calprotectin, Fecal · Immunology
Dec 2017 263d
QUANTA Flash? LKM-1 Reagents, QUANTA Flash? LKM-1 Calibrators, QUANTA Flash? LKM-1 Controls
K163538 · NBS Autoantibodies, Lkm-1... · Immunology
Sep 2017 264d
QUANTA Flash M2 (MIT3), QUANTA Flash M2 (MIT3) Calibrators, QUANTA Flash M2 (MIT3) Controls
K163525 · DBM Antimitochondrial... · Immunology
Sep 2017 264d
NOVA Lite DAPI ANCA Ethanol Kit, NOVA Lite DAPI ANCA Formalin Kit
K161258 · MOB Test System,... · Immunology
Feb 2017 275d
QUANTA Flash Scl-70, QUANTA Flash Scl-70 Calibrators, QUANTA Flash Scl-70 Controls
K152635 · LLL Extractable Antinuclear... · Immunology
Jun 2016 260d
QUANTA Flash dsDNA, QUANTA Flash dsDNA Calibrators and QUANTA Flash dsDNA Controls
K152013 · LSW Anti-dna Antibody,... · Immunology
Apr 2016 265d
QUANTA Flash Jo-1, QUANTA Flash Jo-1 Calibrators, and QUANTA Flash Jo-1 Ciontrols
K151429 · LLL Extractable Antinuclear... · Immunology
Feb 2016 260d
QUANTA Flash B2GP1-Domain1, QUANTA Flash B2GP1-Domain1 Controls, HemosIL AcuStar Anti-B2GPI Domain 1, HemosIL AcuStar Anti-B2GPI Domain 1 Controls
K152875 · MSV System,test,antibodies,b2... · Immunology
Dec 2015 82d
AUTOLoader, and NOVA view with models: ALDR1000, AND NV2000
K153150 · PIV Automated Indirect... · Immunology
Nov 2015 22d
QUANTA Flash CCP3, QUANTA Flash CCP3 Calibrators, and QUANTA Flash CCP3
K143754 · NHX Antibodies, Anti-cyclic... · Immunology
Sep 2015 264d
NOVA View Automated Fluorescense Microscope
DEN140039 · PIV Automated Indirect... · Immunology
Apr 2015 115d
NOVA Lite DAPI ANA Kit
K150155 · DHN Antinuclear Antibody,... · Immunology
Apr 2015 75d
QUANTA FLASH RO52, QUANTA FLASH RO52 CALIBRATORS, AND QUANTA FLASH RO52 CONTROLS
K141655 · OBE Anti-ss-a 52 Autoantibodies · Immunology
Mar 2015 258d
QUANTA FLASH ?2GP1-DOMAIN1; CONTROLS, HEMOSIL ACUSTAR ANTI-?2GPI DOMAIN1; CONTROLS.
K141274 · MSV System,test,antibodies,b2... · Immunology
Feb 2015 273d
QUANTA FLASH RO60, QUANTA FLASH RO60 CALIBRATORS, QUANTA FLASH RO60 CONTROLS
K141328 · LLL Extractable Antinuclear... · Immunology
Feb 2015 267d
QUANTA FLASH SS-B, QUANTA FLASH SS-B CALIBRATORS, AND QUANTA FLASH SS-B CONTROLS
K141210 · LLL Extractable Antinuclear... · Immunology
Jan 2015 265d

Looking for a specific device from Inova Diagnostics, Inc.? Search by device name or K-number.

Search all Inova Diagnostics, Inc. devices
Filters