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
217–240 of 3,794
Search insights Median review: 63d Cleared: 100% Top manufacturer: Inova Diagnostics, Inc. Lead specialty: Immunology
Cleared Jul 28, 2016
AESKUSLIDES ANA HEp-2-Gamma, HELIOS FULLY AUTOMATED IFA SYSTEM
K153117 · DHN
Aesku Systems GmbH&Co.Kg
Immunology · 274d
Cleared Jul 28, 2016
ImmunoCAP Total IgE Calibrator Strip/Total IgE Curve Control Strip, ImmunoCAP...
K161899 · DGC
Phadia AB
Immunology · 17d
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