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
529–552 of 3,792
Search insights Median review: 63d Cleared: 100% Top manufacturer: Inova Diagnostics, Inc. Lead specialty: Immunology
Cleared Dec 06, 2007
ATHENA MULTI-LYTE GBM TEST SYSTEM
K071219 · MVJ
Zeus Scientific, Inc.
Immunology · 218d
Cleared Dec 04, 2007
LEUKO EZ VUE
K071712 · DEG
Techlab Inc., Corporate Research Center
Immunology · 165d
Cleared Nov 30, 2007
FREELITE HUMAN KAPPA AND LAMBDA FREE DIAGNOSTIC TEST KITS FOR USE ON THE...
K070900 · DFH
The Binding Site, Ltd.
Immunology · 242d
Cleared Nov 20, 2007
IMMUNOCAP THYRLOBULIN IMMUNOCAP
K072661 · JNL
Phadia US, Inc.
Immunology · 60d
Cleared Nov 07, 2007
ASCA-CHEK
K071711 · NBT
Techlab Inc., Corporate Research Center
Immunology · 138d
Cleared Nov 07, 2007
KRONUS GAD AUTOANTIBODY ELISA ASSAY KIT
K072135 · NWG
Kronus Market Development Associates,...
Immunology · 97d
Cleared Nov 05, 2007
THERATEST EL-TTG IGA/IGG AND THERATEST EL-GLIA IGA/IGG TEST SYSTEMS
K071692 · MVM
Theratest Laboratories, Inc.
Immunology · 138d
Cleared Nov 05, 2007
IMMULITE 2500 OM-MA, MODEL L5KOP
K072794 · LTK
Siemens Medical Solutions Diagnostics
Immunology · 35d
Cleared Oct 31, 2007
BIOPLEX VASCULITIS KIT
K072358 · MVJ
Bio-Rad Laboratories
Immunology · 70d
Cleared Oct 26, 2007
ACCESS IMMUNOASSAY SYSTEMS BR MONITOR, AND CALIBRATORS, MODEL(S) 387620,AND...
K072612 · MOI
Beckman Coulter, Inc.
Immunology · 39d
Cleared Sep 24, 2007
IMMULISA INTRINSIC FACTOR ANTIBODY ELISA
K071346 · LIG
Immco Diagnostics, Inc.
Immunology · 133d
Cleared Sep 14, 2007
VALIDATE SP1 CALIBRATION VERIFICATION/LINEARITY TEST SET, MODEL 601
K072246 · JJY
Maine Standards Co.
Immunology · 32d
Cleared Sep 11, 2007
DIMENSION VISTA PROTEIN 1 CALIBRATOR, PROTEIN1 CONTROL L,M,H
K071980 · JJY
Dade Behring, Inc.
Immunology · 55d
Cleared Aug 24, 2007
IMMUNOCAP ALLERGEN F338, SCALLOP WITH MODEL(S): 14-4895-01
K071913 · DHB
Phadia AB
Immunology · 44d
Cleared Aug 08, 2007
TRANSFERRIN, SPECICAL CALIBRATOR, SPECITROL AND SPECITROL HIGH CONTROLS
K063086 · DDG
Thermo Electron OY
Immunology · 302d
Cleared Aug 08, 2007
N LATEX RF KIT
K071247 · DHR
Dade Behring, Inc.
Immunology · 96d
Cleared Jul 13, 2007
KRONUS INSULIN AUTOANTIBODY (IAA) ASSAY KIT
K070183 · OCN
Kronus Market Development Associates,...
Immunology · 175d
Cleared Jul 03, 2007
LIQUICHEK TUMOR MARKER CONTROL
K071675 · JJY
Bio-Rad Laboratories
Immunology · 14d
Cleared Jun 21, 2007
FREELITE HUMAN KAPPA AND LAMBDA FREE KITS FOR USE ON THE SPAPLUS ANALYZER
K062372 · DFH
The Binding Site, Ltd.
Immunology · 311d
Cleared Jun 20, 2007
QUANTA PLEX CELIAC IGA PROFILE
K063818 · MVM
Inova Diagnostics, Inc.
Immunology · 180d
Cleared Jun 11, 2007
HYDRAGEL 18 A1AT ISOFOCUSING KIT (PN 4356)
K063498 · OBZ
Sebia
Immunology · 203d
Cleared May 22, 2007
EUROIMMUN ANA IFA: HEP-20-10
K070763 · DHN
Euroimmun Us, LLC
Immunology · 63d
Cleared Apr 30, 2007
DIMENSION VISTA FERRITIN FLEX REAGENT CARTRIDGE (FERR)
K070552 · JIT
Dade Behring, Inc.
Immunology · 62d
Cleared Apr 23, 2007
TRANSFERRIN TIA , CALIBRATOR SET, CONTROL-L,CONTROL-M,CONTROL-H, MODEL#...
K063766 · DDG
Good Biotech Corp.
Immunology · 124d