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
361–384 of 3,794
Search insights Median review: 63d Cleared: 100% Top manufacturer: Inova Diagnostics, Inc. Lead specialty: Immunology
Cleared Mar 30, 2012
BIOPLEX 2200 APLS IGG AND IGA KIT AND CALIBRATOR AND CONTROL SETS
K103834 · MID
Bio-Rad Laboratories
Immunology · 456d
Cleared Feb 27, 2012
HUMAN IGA LIQUID REAGENT KIT FOR USE ON SPA PLUS
K103824 · CFN
The Binding Site
Immunology · 424d
Not Cleared Feb 15, 2012
IMMUNOCAP TRYPTASE, CALIBRATORS, CURVE CONTROL, CONJUGATE 50, CALIBRATOR...
DEN120001 · OYL
Phadia US, Inc.
Immunology · 34d
Cleared Jan 24, 2012
AUDIT(R) MICROLQ(TM) SERUM PROTEIN CONTROL
K112705 · JJY
Aalto Scientific, Ltd.
Immunology · 130d
Cleared Jan 20, 2012
ADVIA CHEMISTRY REAGENTS, AND ADVIA CHEMISTRY B2-MICROGLOBULIN CALIBRATOR
K110874 · JZG
Siemens Healthcare Diagnostics, Inc.
Immunology · 297d
Cleared Jan 06, 2012
IMMULITE 2000 3GALLERGY SPECIFIC IGE ASSAY KIT
K112523 · DHB
Siemens Healthcare Diagnostics, Inc.
Immunology · 128d
Cleared Dec 27, 2011
ACCESS THYROGLOBULIN ANITBODY
K112933 · JNL
Beckman Coulter, Inc.
Immunology · 85d
Cleared Dec 22, 2011
IMMUNOCAP SPECIFIC IGE ALLERGEN BUNDLE, 12 ALLERGEN COMPONENTS
K111919 · DHB
Phadia US, Inc.
Immunology · 168d
Cleared Dec 12, 2011
ZEUS ELISA CARDIOLIPIN IGG/IGM/IGA TEST SYSTEM
K102425 · MID
Zeus Scientific, Inc.
Immunology · 474d
Cleared Dec 02, 2011
IMMULISA SCI-70 ANTIBODY ELISA
K113143 · LLL
Immco Diagnostics, Inc.
Immunology · 38d
Cleared Nov 07, 2011
IT/IF CONTROL
K101863 · JJY
Sebia
Immunology · 493d
Cleared Nov 04, 2011
ACCESS HYBRITECH P2PSA QC ON THE ACCESS IMMUNOASSAY SYSTEMS
K112603 · JJX
Beckman Coulter, Inc.
Immunology · 58d
Cleared Oct 26, 2011
MULTI-ANALYTE DETECTION SYSTEMS
K112810 · NHX
Bio-Rad Laboratories
Immunology · 29d
Cleared Oct 20, 2011
QUANTA FLASH (TM) DGP SCREEN
K111414 · MST
Inova Diagnostics, Inc.
Immunology · 153d
Cleared Oct 13, 2011
IMMUNOFIXATION ELECTROPHORESIS TEST USING INTERLAB G26 INSTRUMENT
K103757 · CFF
Grifols
Immunology · 294d
Cleared Sep 30, 2011
RHEUMATOID FACTOR IMMUNOLOGICAL TEST SYSTEM
K102673 · DHR
Phadia US, Inc.
Immunology · 379d
Cleared Sep 20, 2011
NUCLEIC ACID DETECTION IMMUNOASSAY (NADIA) PSA ASSAY
K101185 · OWM
Iris Molecular Diagnostics
Immunology · 510d
Cleared CT Sep 01, 2011
ROMA (HE4 EIA + ARCHITECT CA 125 II)
K103358 · ONX
Fujirebio Diagnostics,Inc.
Immunology · 289d
Cleared Aug 18, 2011
AXIS-SHIELD ANTI-CCP
K110296 · NHX
Axis-Shield Diagnostics, Ltd.
Immunology · 198d
Cleared Aug 17, 2011
ADVIA CHEMISTRY FERRITIN (FRT) METHOD
K110736 · DBF
Siemens Healthcare Diagnostics, Inc.
Immunology · 154d
Cleared Aug 01, 2011
IMMULITE 2000 3GALLERGY SPECIFIC IGE ASSAY KIT
K101572 · DHB
Siemens Healthcare Diagnostics
Immunology · 423d
Cleared Jul 19, 2011
FUJIREBIO DIAGNOSTICS TUMOR MARKER CONTROL
K103676 · OIU
Fujirebio Diagnostics,Inc.
Immunology · 215d
Cleared Jun 02, 2011
IGX PLEX CELIAC QUALITATIVE ASSAY
K102490 · MVM
Sqi Diagnostics Systems
Immunology · 275d
Cleared Jun 02, 2011
ADVIA CENTAUR CALIBARATOR 80 MODEL 10492491
K103548 · JIT
Siemens Healthcare Diagnostics, Inc.
Immunology · 181d