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
817–840 of 3,794
Search insights Median review: 63d Cleared: 100% Top manufacturer: Inova Diagnostics, Inc. Lead specialty: Immunology
Cleared Dec 17, 2002
IMMULITE 2000 ALLERGEN-SPECIFIC IGE
K023152 · DHB
Diagnostic Products Corp.
Immunology · 85d
Cleared Dec 17, 2002
ST AIA-PACK AFP ENZYME IMMUNOASSAY
K023894 · LOJ
Tosoh Medics, Inc.
Immunology · 25d
Cleared Dec 13, 2002
K-ASSAY LP(A) CONTROLS
K023853 · DFC
Kamiya Biomedical Co.
Immunology · 24d
Cleared Dec 11, 2002
ACCESS OV MONITOR IMMUNOENZYMETRIC ASSAY
K023597 · LTK
Beckman Coulter, Inc.
Immunology · 44d
Cleared Dec 06, 2002
ST AIA-PACK CA 125 ENZYME IMMUNOASSAY
K023891 · LTK
Tosoh Medics, Inc.
Immunology · 14d
Cleared Dec 03, 2002
ORION DIAGNOSTICA ULTRASENSITIVE CRP KIT, MODEL 68025, & ORION DIAGNOSTICA...
K022176 · DCK
Orion Diagnostica, Div. Orion Corp.
Immunology · 153d
Cleared Nov 27, 2002
CA 125 II ASSAY FOR THE BAYER ADVIA INTEGRATED MODULE SYSTEM
K022329 · LTK
Bayer Diagnostics Corp.
Immunology · 132d
Cleared Nov 25, 2002
VISIQUANT ANTI-NUCLEAR ANTIBODY TEST SYSTEM
K022800 · DHN
Hyperion, Inc.
Immunology · 94d
Cleared Nov 13, 2002
VARELISA CARDIOLIPIN ANTIBODIES SCREEN, MODELS 15848 AND 15896
K023433 · MID
Pharmacia Diagnostics GmbH & Co. KG
Immunology · 29d
Cleared Nov 12, 2002
CA 15-3 ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM
K022178 · MOI
Bayer Diagnostics Corp.
Immunology · 132d
Cleared Oct 28, 2002
TRUCATH.IP
K023368 · DFG
Aortech Critical Care , Ltd.
Immunology · 20d
Cleared Oct 09, 2002
DIASTAT ANTI CYCLIC CITRULLINATED PEPTIDE (ANTI-CCP) ELISA
K023285 · NHX
Axis-Shield Diagnostics, Ltd.
Immunology · 23d
Cleared Oct 01, 2002
AFP ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM
K020807 · LOJ
Bayer Diagnostics Corp.
Immunology · 203d
Cleared Sep 25, 2002
REAADS IGA ANTI-CARDIOLIPIN SEMI-QUANTITATIVE TEST KIT, MODEL 026-001
K022990 · MID
Corgenix, Inc.
Immunology · 16d
Cleared Sep 25, 2002
REAADS ANTI-CARDIOLIPIN IGG/IGM SEMI-QUANTITATIVE TEST KIT, MODEL 023-001
K022992 · MID
Corgenix, Inc.
Immunology · 16d
Cleared Sep 23, 2002
CRPEX CRP CONTROLS LEVEL L, M, H
K022725 · JJX
Good Biotech Corp.
Immunology · 38d
Cleared Sep 20, 2002
QUANTA LITE ACTIN (ANTI-SMOOTH MUSCLE) ELISA
K021648 · NJF
Inova Diagnostics, Inc.
Immunology · 123d
Cleared Sep 19, 2002
MY ALLERGY TEST
K021698 · JKA
Immunetech Corporation
Immunology · 120d
Cleared Sep 17, 2002
BRAHMS DIAGNOSTICA DYNOTEST TG-PLUS
K021057 · MSW
Brahms Diagnostica, LLC
Immunology · 169d
Cleared Sep 17, 2002
LIQUICHEK IMMUNOLOGY CONTROL LEVEL 1, 2, AND 3-1 ML, MODEL 591, 592, 593
K022991 · JJY
Bio-Rad
Immunology · 8d
Cleared Sep 11, 2002
CONVOY ADVANCED DELIVERY SHEATH
K022067 · DBY
Boston Scientific
Immunology · 78d
Cleared Sep 09, 2002
WAKO RF-HA (2), RF CALIBRATOR, RF CALIBRATOR SET
K020972 · DHR
Wako Chemicals USA, Inc.
Immunology · 167d
Cleared Aug 27, 2002
APL IGA ELISA KIT
K021398 · MID
Louisville Apl Diagnostics, Inc.
Immunology · 117d
Cleared Aug 15, 2002
MININEPH HUMAN B2-MICROGLOBULIN KIT
K014270 · JZG
The Binding Site, Ltd.
Immunology · 231d