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
817–840 of 3,792
Search insights Median review: 63d Cleared: 100% Top manufacturer: Inova Diagnostics, Inc. Lead specialty: Immunology
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
Cleared Aug 15, 2002
LIQUICHEK BLOOD GAS PLUS CO-OXIMETER CONTROL (RADIOMETER 700 SERIES) LEVELS,...
K022525 · JJS
Bio-Rad
Immunology · 15d
Cleared Aug 14, 2002
RHIGENE MESACUP-2 TEST RNP, MODEL M7741
K022017 · LKO
Rhigene, Inc.
Immunology · 55d