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
529–552 of 3,794
Search insights Median review: 63d Cleared: 100% Top manufacturer: Inova Diagnostics, Inc. Lead specialty: Immunology
Cleared Dec 19, 2007
QUANTIA BETA-2 MICROGLOBULIN, MODEL: 302822307
K072078 · JZG
Biokit, S.A.
Immunology · 142d
Cleared Dec 07, 2007
ELIA DSDNA IMMUNOASSAY, MODEL 14-5500-01, ELIA ANA CONTROL, MODEL 83-1004-01
K072393 · LSW
Phadia US, Inc.
Immunology · 102d
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