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
217–240 of 3,792
Search insights Median review: 63d Cleared: 100% Top manufacturer: Inova Diagnostics, Inc. Lead specialty: Immunology
Cleared Jul 22, 2016
KRONUS Aquaporin-4 Autoantibody (AQP4Ab) ELISA Assay
K161951 · PNI
Kronus, Inc.
Immunology · 7d
Cleared Jun 17, 2016
Image Navigator by Immuno Concepts
K160265 · DHN
Immuno Concepts, N.A. , Ltd.
Immunology · 136d
Cleared Jun 16, 2016
Optilite Hevylite IgA Kappa Kit, Optilite Hevylite IgA Lambda Kit
K160819 · OPX
The Binding Site Group , Ltd.
Immunology · 84d
Cleared Jun 15, 2016
ROMA Calculation Tool Using Elecsys Assays
K153607 · ONX
Roche Diagnostics
Immunology · 181d
Cleared Jun 07, 2016
Beta-2-Microglobulin
K161297 · JZG
Beckman Coulter Ireland, Inc.
Immunology · 29d
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 May 16, 2016
Lumipulse G ROMA
K160090 · ONX
Fujirebio Diagnostics,Inc.
Immunology · 122d
Cleared Apr 28, 2016
ARCHITECT ROMA
K151502 · ONX
Fujirebio Diagnostics,Inc.
Immunology · 329d
Not Cleared Apr 25, 2016
KRONUS Aquaporin-4 Autoantibody (AQP4Ab) ELISA Assay
DEN150030 · PNI
Kronus, Inc.
Immunology · 298d
Cleared Apr 11, 2016
QUANTA Flash dsDNA, QUANTA Flash dsDNA Calibrators and QUANTA Flash dsDNA...
K152013 · LSW
Inova Diagnostics, Inc.
Immunology · 265d
Cleared Mar 25, 2016
EliA anti-TG Immunoassay, EliA anti-TPO Immunoassay, EliA Thyroid Positive...
K151799 · JZO
Phadia AB
Immunology · 267d
Cleared Mar 18, 2016
OVA1 Next Generation
K150588 · ONX
Vermillion, Inc.
Immunology · 375d
Cleared Mar 11, 2016
ImmuLisa Enhanced Centromere Antibody ELISA
K151559 · LJM
Immco Diagnostics, Inc.
Immunology · 275d
Cleared Mar 10, 2016
QuikRead go CRP, QuikRead go CRP Verification Set, QuikRead go CRP Control...
K142993 · DCK
Orion Diagnostica, OY
Immunology · 511d
Cleared Mar 03, 2016
IMMULITE 2000 TSI Assay, IMMULITE 2000 TSI Calibration Verification Material
K152061 · JZO
Siemens Healthcare Diagnostics, Inc.
Immunology · 223d
Cleared Feb 29, 2016
ImmunoCAP Allergen d202, Allergen component rDer p 1,House dust mite
K150597 · DHB
Phadia AB
Immunology · 357d
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 Jan 19, 2016
Phadia Prime
K151029 · DHB
Phadia AB
Immunology · 277d
Cleared Dec 21, 2015
QUANTA Flash B2GP1-Domain1, QUANTA Flash B2GP1-Domain1 Controls, HemosIL...
K152875 · MSV
Inova Diagnostics, Inc.
Immunology · 82d
Cleared Dec 18, 2015
Optilite Hevylite IgM Kappa Kit
K152389 · PDE
The Binding Site Group , Ltd.
Immunology · 116d
Cleared Dec 17, 2015
BD FACSPresto System, BD FACSPresto CD4/Hb Cartridge, BD FACSPresto CD4/Hb...
K150815 · PMG
Becton, Dickinson and Company
Immunology · 265d
Cleared Dec 14, 2015
ImmunoCAP Specific IgE
K150854 · DHB
Phadia AB
Immunology · 258d
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