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
265–288 of 3,794
Search insights Median review: 63d Cleared: 100% Top manufacturer: Inova Diagnostics, Inc. Lead specialty: Immunology
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
Cleared Dec 24, 2014
IMMULITE 2000 Ferritin Calibration Verification Material, IMMULITE 2000...
K143352 · JJX
Siemens Healthcare Diagnostics, Inc.
Immunology · 30d
Cleared Dec 23, 2014
ADIVA Centaur Progesterone Master Curve Material (MCM), ADIVA Centaur...
K143376 · JJX
Siemens Healthcare Diagnostics, Inc.
Immunology · 28d
Cleared Dec 21, 2014
The Optilite IgG3 kit
K142735 · CFN
The Binding Site Group , Ltd.
Immunology · 89d
Cleared Dec 09, 2014
EUROIMMUN EUROLINE ENA PROFILE 9AG (IGG)
K140224 · LKO
Euroimmun US
Immunology · 314d
Cleared Nov 06, 2014
IG_PLEX CELIAC DGP PANEL
K140691 · MVM
Sqi Diagnostics Systems, Inc.
Immunology · 232d
Cleared Oct 30, 2014
ELIA SCL-70S IMMUNOASSAY
K140493 · LJM
Phadia GmbH
Immunology · 245d
Cleared Oct 27, 2014
ELIA PR3S IMMUNOASSAY, ELIA MPOS IMMUNOASSAY, ELIA GBM IMMUNOASSAY, ELIA...
K140225 · MOB
Phadia US, Inc.
Immunology · 271d
Cleared Aug 29, 2014
EIA SMDP IMMUNOASSAY
K132631 · LKP
Phadia US, Inc.
Immunology · 372d
Not Cleared Aug 20, 2014
ZINC TRANSPORTER 8 ANTIBODY (ZNT8AB) ELISA ASSAY KIT
DEN140001 · PHF
Kronus Market Development Associates,...
Immunology · 65d
Cleared Aug 06, 2014
HEVYLITE HUMAN IGM KAPPA AND LAMBDA KIT FOR USE ON SPAPLUS
K140686 · PDE
The Binding Site Group , Ltd.
Immunology · 140d
Cleared Jul 18, 2014
OPTILITE C1 INACTIVATOR KIT
K141100 · DBA
The Binding Site Group , Ltd.
Immunology · 80d
Cleared Jun 27, 2014
EUROIMMUN ANTI-PLA2R ELISA (IGG)
K132195 · PGV
Euroimmun Us, Inc.
Immunology · 347d
Cleared Jun 24, 2014
DIAZYME FERRITIN ASSAY, DIAZYME FERRITIN CALIBRATOR SET, DIAZYME FERRITIN...
K133083 · DBF
Diazyme Laboratories
Immunology · 267d
Cleared Jun 24, 2014
IMMULITE 2000 FREE PSA CALIBRATION VERIFICATION MATERIAL
K133816 · JJX
Siemens Healthcare Diagnostics, Inc.
Immunology · 190d
Cleared Jun 23, 2014
LIQUICHEK TUMOR MARKER CONTROL
K141073 · JJY
Bio-Rad Laboratories
Immunology · 59d
Cleared Jun 06, 2014
CA 125 II CALSET II
K140112 · JIT
Roche Diagnostics
Immunology · 142d
Not Cleared May 29, 2014
EUROIMMUN ANTI-PLA2R IFA
DEN140002 · PGV
Euroimmun US
Immunology · 62d
Cleared May 28, 2014
IMMULITE 2000 SYSTEMS 3GALLERGY SPECIFIC IGE ASSAY
K132801 · DHB
Siemens Healthcare Diagnostics, Inc.
Immunology · 257d
Cleared Apr 25, 2014
LIQUICHEK IMMUNOLOGYCONTROL-LEVEL 1,LEVEL 2, LEVEL 3, MINIPAK
K140764 · JJY
Bio-Rad Laboratories
Immunology · 29d
Cleared Apr 24, 2014
LYPHOCHEK ALLERGEN SIGE CONTROL, NEGATIVE, LYPOCHEK ALLERGEN SIGE CONTROL,...
K134013 · JJY
Bio-Rad Laboratories
Immunology · 115d
Cleared Apr 16, 2014
FREELITE HUMAN LAMBDA FREE KIT
K140396 · DEH
The Binding Site Group , Ltd.
Immunology · 57d
Cleared Apr 16, 2014
HUMAN ALPHA2-MACROGLOBULIN KIT FOR USE ON SPAPLUS
K140664 · DEB
The Binding Site Group , Ltd.
Immunology · 29d