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
265–288 of 3,792
Search insights Median review: 63d Cleared: 100% Top manufacturer: Inova Diagnostics, Inc. Lead specialty: Immunology
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
Cleared Mar 18, 2014
HEVYLITE HUMAN IGA KAPPA KIT FOR USE ON SIEMENS BNII, HEVYLITE HUMAN IGA...
K140105 · OPX
The Binding Site
Immunology · 62d
Cleared Feb 26, 2014
IFA 40: HEP-20-10
K131791 · DHN
Euroimmun US
Immunology · 253d