Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Immunology ×
3,794 results
241–264 of 3,794
Search insights Median review: 63d Cleared: 100% Top manufacturer: Inova Diagnostics, Inc. Lead specialty: Immunology
Cleared Nov 24, 2015
Lumipulse G HE4 Immunoreaction Cartridges, Lumipulse G HE4 Calibrators
K151378 · OIU
Fujirebio Diagnostics,Inc.
Immunology · 186d
Cleared Nov 24, 2015
AUTOLoader, and NOVA view with models: ALDR1000, AND NV2000
K153150 · PIV
Inova Diagnostics, Inc.
Immunology · 22d
Cleared Nov 06, 2015
Hevylite Human IgA Kappa Kit for use on SPAPLUS, Hevylite Human IgA Lambda...
K151759 · OPX
The Binding Site Group , Ltd.
Immunology · 130d
Cleared Sep 24, 2015
VITROS Chemistry Products CRP Slides
K152433 · DCK
Ortho-Clinical Diagnostics
Immunology · 28d
Cleared Sep 23, 2015
ImmuLisa Enhanced RF IgA Antibody ELISA, ImmuLisa Enhanced RF IgG Antibody...
K143736 · DHR
Immco Diagnostics, Inc.
Immunology · 267d
Cleared Sep 21, 2015
QUANTA Flash CCP3, QUANTA Flash CCP3 Calibrators, and QUANTA Flash CCP3
K143754 · NHX
Inova Diagnostics, Inc.
Immunology · 264d
Cleared Aug 28, 2015
Optilite CH50 Reagent, Optilite CH50 Controls and Optilite CH50 Calibrator
K150412 · DAE
The Binding Site Group , Ltd.
Immunology · 191d
Cleared Aug 26, 2015
Optilite FreeLite Kappa Free Kit, Optilite Freelite Lambda Free Kit
K150658 · DFH
The Binding Site Group , Ltd.
Immunology · 166d
Cleared Aug 06, 2015
Elecsys CA-125 II assay
K143534 · LTK
Roche Professional Diagnostics
Immunology · 237d
Cleared May 30, 2015
Optilite IgG4 Kit
K150526 · CFN
The Binding Site Group , Ltd.
Immunology · 89d
Cleared May 21, 2015
LUMIPULSE G1200 System, LUMIPULSE G CA 125II Immunoreaction Cartridges,...
K142895 · LTK
Fujirebio Diagnostics,Inc.
Immunology · 230d
Cleared Apr 17, 2015
EUROIMMUN IFA 40: HEP-20-10
K141827 · DHN
Euroimmun Us, Inc.
Immunology · 284d
Cleared Apr 10, 2015
AQUIOS CL FLOW CYTOMETER, AQUIOS TETRA-1 PANEL,AQUIOS TETRA-2+PANEL, AQUIOS...
K141932 · OYE
Beckman Coulter, Inc.
Immunology · 268d
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 31, 2015
ImmuLisa Enhanced SS-A (Ro) Antibody ELISA, ImmuLisa Enhanced SS-B (La)...
K142781 · LLL
Immco Diagnostics, Inc.
Immunology · 186d
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 27, 2015
BD FACSCanto II flow cytometer (4-2-2 and 5-3 configurations), BD FACSCanto...
K141468 · OYE
Bd Biosciences
Immunology · 269d
Cleared Feb 13, 2015
QUANTA FLASH ¿2GP1-DOMAIN1
K141274 · MSV
Inova Diagnostics, Inc.
Immunology · 273d
Cleared Feb 13, 2015
ELIA M2
K141375 · DBM
Phadia US, Inc.
Immunology · 262d
Cleared Feb 12, 2015
QUANTA FLASH RO60, QUANTA FLASH RO60 CALIBRATORS, QUANTA FLASH RO60 CONTROLS
K141328 · LLL
Inova Diagnostics, Inc.
Immunology · 267d
Cleared Jan 29, 2015
QUANTA FLASH SS-B, QUANTA FLASH SS-B CALIBRATORS, AND QUANTA FLASH SS-B CONTROLS
K141210 · LLL
Inova Diagnostics, Inc.
Immunology · 265d
Cleared Jan 27, 2015
ADVIA Centaur IgE Master Curve Material
K143680 · JJX
Siemens Healthcare Diagnostics, Inc.
Immunology · 34d
Cleared Jan 23, 2015
IMMULITE 2000 CEA Calibration Verification Material
K143639 · JJX
Siemens Healthcare Diagnostics
Immunology · 32d