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
721–744 of 3,792
Search insights Median review: 63d Cleared: 100% Top manufacturer: Inova Diagnostics, Inc. Lead specialty: Immunology
Cleared Mar 05, 2004
IMMULISA ANTI-HUMAN TISSUE TRANSGLUTAMINASE (HU-TTG) ANTIBODY TOTAL IGA/IGG...
K040095 · MVM
Immco Diagnostics, Inc.
Immunology · 45d
Cleared Mar 04, 2004
MESACUP-2 TEST CENP-B
K040200 · LJM
Rhigene, Inc.
Immunology · 35d
Cleared Feb 27, 2004
ATHENA MULTI-LITE RHEUMATOID FACTOR IGM TEST SYSTEM
K033802 · DHR
Zeus Scientific, Inc.
Immunology · 81d
Cleared Feb 03, 2004
BR MONITOR AND BR MONITOR CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS,...
K033036 · MOI
Beckman Coulter, Inc.
Immunology · 127d
Cleared Jan 30, 2004
FREELITE HUMAN KAPPA AND LAMBDA FREE KITS FOR USE ON THE OLYMPUS AU ANALYZER
K033811 · DEH
The Binding Site, Ltd.
Immunology · 52d
Cleared Jan 22, 2004
DAKOCYTOMATION BETA-2-MICROGLOBULIN KIT, CODE NO. OA 368
K032692 · JZG
Dako A/S
Immunology · 142d
Cleared Jan 22, 2004
MODIFICATION TO VYSIS UROVYSION BLADDER CANCER RECURRENCE TEST
K033982 · MMW
Vysis
Immunology · 30d
Cleared Jan 20, 2004
AUTOSTAT II ANTI-TISUE TRANSGLUTAMINASE IGA ELISA
K033744 · MVM
Hycor Biomedical , Ltd.
Immunology · 50d
Cleared Jan 13, 2004
IBL C3D-CIC EIA TEST
K032796 · CZW
Ibl GmbH
Immunology · 127d
Cleared Jan 08, 2004
REAADS DSDNA QUANTITATIVE TEST KIT, MODEL 022-001
K034013 · LKJ
Corgenix, Inc.
Immunology · 15d
Cleared Dec 29, 2003
GI MONITOR AND GI MONITOR CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS,...
K033038 · NIG
Beckman Coulter, Inc.
Immunology · 91d
Cleared Dec 24, 2003
IMMULISA ANTI-HUMAN TISSUE TRANSGLUTAMINASE (HU-TTG) ANTIBODY IGA ELISA
K032571 · MVM
Immco Diagnostics, Inc.
Immunology · 126d
Cleared Dec 22, 2003
MESACUP-2 TEST JO-1, MODEL 10756
K033528 · LLL
Rhigene, Inc.
Immunology · 45d
Cleared Dec 19, 2003
IMMUNETECH TOTAL IGE SYSTEM
K032251 · DGC
Immunetech Corporation
Immunology · 150d
Cleared Dec 16, 2003
AESKULISA ANA 8PRO
K032469 · LLL
Aesku, Inc.
Immunology · 127d
Cleared Nov 19, 2003
INTERLAB IMMUNOFIXATION TEST(S)
K033187 · CFF
Interlab S.R.L.
Immunology · 49d
Cleared Nov 04, 2003
HYDRAGEL CSF ISOFOCUSING KITS
K033277 · CFF
Morax
Immunology · 25d
Cleared Oct 14, 2003
REAADS II ANTI-CARDIOLIPIN IGG SEMI-QUANTITATIVE TEST KIT, MODEL 11139
K032868 · MID
Corgenix, Inc.
Immunology · 29d
Cleared Oct 10, 2003
ORION DIAGNOSTICA QUIKREAD CRP KIT AND QUIKREAD CRP CONTROL
K031607 · DCK
Orion Diagnostica, Div. Orion Corp.
Immunology · 141d
Cleared Sep 29, 2003
BINDAZYME HUMAN ANTI-PHOSPHATIDYLSERINE IGA, IGG AND IGM ENZYME IMMUNOASSAY KIT
K032240 · MID
The Binding Site, Ltd.
Immunology · 70d
Cleared Sep 26, 2003
RHIGENE MESACUP-2 ANTI-MITOCHONDRIA M2 TEST, MODEL 10760
K031308 · DBM
Rhigene, Inc.
Immunology · 155d
Cleared Sep 10, 2003
BINDAZYME CLQ CIC EIA KIT
K031563 · DAK
The Binding Site, Ltd.
Immunology · 114d
Cleared Sep 10, 2003
TSH RECEPTOR ANTIBODY (TRAB) COATED TUBE (CT) ASSAY KIT
K032134 · JZO
Kronus Market Development Associates,...
Immunology · 61d
Cleared Sep 10, 2003
MODIFICATION TO:ROCHE DIAGNOSTICS TINA-QUANT RHEUMATOID FACTORS II TEST SYSTEM
K032535 · DHR
Roche Diagnostics Corp.
Immunology · 23d