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
721–744 of 3,794
Search insights Median review: 63d Cleared: 100% Top manufacturer: Inova Diagnostics, Inc. Lead specialty: Immunology
Cleared Mar 09, 2004
LACRYTEST
K034057 · DGC
Adiatec SA
Immunology · 70d
Cleared Mar 08, 2004
QUANTA PLEX SLE PROFILE 8
K040160 · LLL
Inova Diagnostics, Inc.
Immunology · 45d
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