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
673–696 of 3,792
Search insights Median review: 63d Cleared: 100% Top manufacturer: Inova Diagnostics, Inc. Lead specialty: Immunology
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
Cleared Jun 17, 2004
VITROS IMMUNODIAGNOSTIC PRODUCTS CEA REAGENT PACK/CALIBRATOR/RANGE VERIFIERS
K041322 · DHX
Ortho-Clinical Diagnostics, Inc.
Immunology · 30d
Cleared Jun 16, 2004
BIOCHECK CARDIAC-1 CRP RAPID TEST, MODEL BC-804114
K040030 · DCN
Biocheck, Inc.
Immunology · 161d