FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Immunology ×
3,792 results
241–264 of 3,792
Search insights Median review: 63d Cleared: 100% Top manufacturer: Inova Diagnostics, Inc. Lead specialty: Immunology
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
Cleared Jan 16, 2015
Audit MicroControls Linearity FD Tumor Markers II
K143573 · JJY
Aalto Scientific, Ltd.
Immunology · 30d
Cleared Jan 08, 2015
MINICAP Immunotyping using the MINICAP and the MINICAP FLEX-PIERCING
K143483 · CFF
Sebia
Immunology · 31d