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
673–696 of 3,794
Search insights Median review: 63d Cleared: 100% Top manufacturer: Inova Diagnostics, Inc. Lead specialty: Immunology
Cleared Nov 22, 2004
BINDING SITE IGG SUBLCASS OLYMPUS KITS
K042152 · CFN
The Binding Site
Immunology · 105d
Cleared Nov 19, 2004
RHIGENE HEP-ANA TEST SYSTEM
K042680 · DHN
Corgenix, Inc.
Immunology · 51d
Cleared Nov 19, 2004
ARCHITECT CA 125 II ASSAY
K042731 · LTK
Fujirebio Diagnostics,Inc.
Immunology · 49d
Cleared Nov 10, 2004
VITROS CHEMISTRY PRODUCTS IGG, IGA AND IGM REAGENTS
K042475 · CFN
Ortho-Clinical Diagnostics, Inc.
Immunology · 58d
Cleared Nov 05, 2004
MININEPH HUMAN RHEUMATOID FACTOR KIT
K041891 · DHR
The Binding Site
Immunology · 116d
Cleared Nov 05, 2004
QUEST TUMOR MARKER CONTROL, MODEL 955
K042815 · JJY
Bio-Rad
Immunology · 24d
Cleared Oct 26, 2004
IMMULISA ANTINUCLEAR ANTIBODY SCREEN ELISA
K041102 · LJM
Immco Diagnostics, Inc.
Immunology · 182d
Cleared Oct 20, 2004
IBD-SCAN
K042071 · DEG
Techlab, Inc.
Immunology · 79d
Cleared Oct 19, 2004
VITROS CHEMISTRY PRODUCTS C3 AND CR REAGENT, CALIBRATOR KIT 20, PROTEIN...
K042494 · CZW
Ortho-Clinical Diagnostics
Immunology · 35d
Cleared Oct 14, 2004
WIDE RANGE C-REACTIVE PROTEIN (WR CRP) ASSAY
K041155 · DCK
Stanbio Laboratory
Immunology · 164d
Cleared Oct 14, 2004
AESKULISA DS DNA G
K041628 · LSW
Aesku Diagnostics
Immunology · 120d
Cleared Oct 08, 2004
ATHENA MULTI-LYTE ANA-II TEST SYSTEM
K042416 · LKJ
Zeus Scientific, Inc.
Immunology · 31d
Cleared Sep 24, 2004
FIDIS CELIAC
K041002 · MST
Biomedical Diagnostics S.A.
Immunology · 158d
Cleared Sep 20, 2004
VITROS CHEMISTRY PRODUCTS RF REAGENT, VITROS CHEMISTRY PRODUCTS CALIBRATOR...
K041863 · DHR
Ortho-Clinical Diagnostics, Inc.
Immunology · 73d
Cleared Sep 17, 2004
ARCHITECT FREE PSA MASTERCHECK, MODEL 6C07-05
K042335 · JJY
Bio-Rad Laboratories, Inc.
Immunology · 18d
Cleared Aug 02, 2004
CELIKEY IGG ITG IGG ANTIBODIES, MODEL 17996
K041173 · MVM
Sweden Diagnostics (Germany) GmbH
Immunology · 89d
Cleared Aug 02, 2004
VARELISA GLIADIN IGG ANTIBODIES
K041357 · MST
Sweden Diagnostics (Germany) GmbH
Immunology · 74d
Cleared Jul 19, 2004
CELIKEY TTG (HUMAN, RECOMBINANT) IGA ANTIBODIES MODEL #18148/18196
K041174 · MVM
Sweden Diagnostics (Germany) GmbH
Immunology · 75d
Cleared Jul 16, 2004
BINDAZYME HUMAN ANTI TISSUE TRANSGLUTAMINASE IGA AND IGG EIA DIAGNOSTIC TEST...
K040466 · MVM
The Binding Site
Immunology · 144d
Cleared Jul 16, 2004
VARELISA GLIADIN IGA ANTIBODIES MODEL #19848/19896
K041354 · MST
Sweden Diagnostics (Germany) GmbH
Immunology · 57d
Cleared Jul 14, 2004
AESKULISA ENA 6 S
K041753 · LLL
Aesku Diagnostics
Immunology · 15d
Cleared Jul 02, 2004
VARELISA PR3 ANCA, MODEL NUMBER 17748/17796
K041043 · MOB
Pharmacia Deutschland GmbH
Immunology · 71d
Cleared Jun 25, 2004
QUANTA LITE GP210 ELISA
K040885 · NRI
Inova Diagnostics, Inc.
Immunology · 81d
Cleared Jun 23, 2004
AESKULISA ANA HEP-2
K040953 · LJM
Aesku, Inc.
Immunology · 72d