Search FDA 510(k) Devices

4,872 clearances indexed · Search by device name, K-number, manufacturer or product code

138 results for "Inova Diagnostics, Inc."
1–24 of 138
Cleared Feb 06, 2026
Aptiva APS IgA Reagent
K243979 · MSV
Inova Diagnostics, Inc.
Immunology · 410d
Cleared Dec 17, 2024
Aptiva APS IgG Reagent
K223093 · MID
Inova Diagnostics, Inc.
Immunology · 809d
Cleared Sep 29, 2023
Aptiva CTD Essential Reagent
K213403 · LLL
Inova Diagnostics, Inc.
Immunology · 711d
Cleared Aug 26, 2021
Aptiva Celiac Disease IgG Reagent
K200230 · MVM
Inova Diagnostics, Inc.
Immunology · 574d
Cleared Jun 16, 2021
Aptiva Celiac Disease IgA Reagent
K193604 · MVM
Inova Diagnostics, Inc.
Immunology · 541d
Cleared Dec 11, 2020
NOVA Lite DAPI dsDNA Crithidia luciliae Kit
K192916 · KTL
Inova Diagnostics, Inc.
Immunology · 423d
Cleared Apr 17, 2019
QUANTA Flash RF IgM Reagents, QUANTA Flash RF IgA Reagents
K190088 · DHR
Inova Diagnostics, Inc.
Immunology · 90d
Cleared Oct 16, 2018
QUANTA Flash Calprotectin and Fecal Extraction Device
K180971 · NXO
Inova Diagnostics, Inc.
Immunology · 186d
Cleared Jun 25, 2018
QUANTA Flash HMGCR Reagents
K180975 · LLL
Inova Diagnostics, Inc.
Immunology · 73d
Cleared Dec 22, 2017
QUANTA Flash Calprotectin Reagents, QUANTA Flash Calprotectin Calibrators,...
K170993 · NXO
Inova Diagnostics, Inc.
Immunology · 263d
Cleared Sep 06, 2017
QUANTA Flash® LKM-1 Reagents, QUANTA Flash® LKM-1 Calibrators, QUANTA Flash®...
K163538 · NBS
Inova Diagnostics, Inc.
Immunology · 264d
Cleared Sep 05, 2017
QUANTA Flash M2 (MIT3), QUANTA Flash M2 (MIT3) Calibrators, QUANTA Flash M2...
K163525 · DBM
Inova Diagnostics, Inc.
Immunology · 264d
Cleared Feb 03, 2017
NOVA Lite DAPI ANCA Ethanol Kit, NOVA Lite DAPI ANCA Formalin Kit
K161258 · MOB
Inova Diagnostics, Inc.
Immunology · 275d
Cleared Jun 01, 2016
QUANTA Flash Scl-70, QUANTA Flash Scl-70 Calibrators, QUANTA Flash Scl-70...
K152635 · LLL
Inova Diagnostics, Inc.
Immunology · 260d
Cleared Apr 11, 2016
QUANTA Flash dsDNA, QUANTA Flash dsDNA Calibrators and QUANTA Flash dsDNA...
K152013 · LSW
Inova Diagnostics, Inc.
Immunology · 265d
Cleared Feb 12, 2016
QUANTA Flash Jo-1, QUANTA Flash Jo-1 Calibrators, and QUANTA Flash Jo-1...
K151429 · LLL
Inova Diagnostics, Inc.
Immunology · 260d
Cleared Dec 21, 2015
QUANTA Flash B2GP1-Domain1, QUANTA Flash B2GP1-Domain1 Controls, HemosIL...
K152875 · MSV
Inova Diagnostics, Inc.
Immunology · 82d
Cleared Nov 24, 2015
AUTOLoader, and NOVA view with models: ALDR1000, AND NV2000
K153150 · PIV
Inova Diagnostics, Inc.
Immunology · 22d
Cleared Sep 21, 2015
QUANTA Flash CCP3, QUANTA Flash CCP3 Calibrators, and QUANTA Flash CCP3
K143754 · NHX
Inova Diagnostics, Inc.
Immunology · 264d
Not Cleared Apr 09, 2015
NOVA View Automated Fluorescense Microscope
DEN140039 · PIV
Inova Diagnostics, Inc.
Immunology · 115d
Cleared Apr 08, 2015
NOVA Lite DAPI ANA Kit
K150155 · DHN
Inova Diagnostics, Inc.
Immunology · 75d
Cleared Mar 05, 2015
QUANTA FLASH RO52, QUANTA FLASH RO52 CALIBRATORS, AND QUANTA FLASH RO52 CONTROLS
K141655 · OBE
Inova Diagnostics, Inc.
Immunology · 258d
Cleared Feb 13, 2015
QUANTA FLASH ¿2GP1-DOMAIN1
K141274 · MSV
Inova Diagnostics, Inc.
Immunology · 273d
Cleared Feb 12, 2015
QUANTA FLASH RO60, QUANTA FLASH RO60 CALIBRATORS, QUANTA FLASH RO60 CONTROLS
K141328 · LLL
Inova Diagnostics, Inc.
Immunology · 267d