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
697–720 of 3,794
Search insights Median review: 63d Cleared: 100% Top manufacturer: Inova Diagnostics, Inc. Lead specialty: Immunology
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
Cleared Jun 16, 2004
VARELISA MPO ANCA, MODEL 17648/17696
K041040 · MOB
Sweden Diagnostics (Germany) GmbH
Immunology · 55d
Cleared May 14, 2004
VARELISA HISTONE ANTIBODIES, MODEL 16496
K040810 · LJM
Pharmacia Deutschland GmbH
Immunology · 46d
Cleared May 13, 2004
VARELISA SSDNA ANTIBODIES, MODEL 14896
K040811 · LRM
Pharmacia Deutschland GmbH
Immunology · 45d
Cleared May 12, 2004
AESKULISA CARDIOLIPIN AGM
K040463 · MID
Aesku, Inc.
Immunology · 79d
Cleared May 11, 2004
VARELISA B2 GLYCOPROTEIN I IGG ANTIBODIES, MODELS 18748 AND 18796
K040449 · MSV
Pharmacia Deutschland GmbH
Immunology · 81d
Cleared May 11, 2004
VARELISA B2 GLYCOPROTEIN I IGA ANTIBODIES, MODELS 18948 AND 18996
K040450 · MSV
Pharmacia Deutschland GmbH
Immunology · 81d
Cleared May 11, 2004
VARELISA B2 GLYCOPROTEIN I IGM ANTIBODIES, MODELS 18848 AND 18896
K040451 · MSV
Pharmacia Deutschland GmbH
Immunology · 81d
Cleared May 11, 2004
VARELISA B2 GLYCOPROTEIN I ANTIBODIES SCREEN, MODELS 19048 AND 19096
K040452 · MSV
Pharmacia Deutschland GmbH
Immunology · 81d
Cleared May 10, 2004
QUANTEX FERRITIN
K040879 · DBF
Instrumentation Laboratory CO
Immunology · 35d
Cleared Apr 28, 2004
NORMAL AND HYPERGAMMA CONTROL SERUM
K040925 · JJY
Sebia
Immunology · 20d
Cleared Apr 05, 2004
ZEUS SCIENTIFIC, INC., ATHENA MULTI-LYTE MPO/PR3 IGG TEST SYSTEM
K040111 · MOB
Zeus Scientific, Inc.
Immunology · 76d
Cleared Apr 02, 2004
MESACUP TEST PR-3
K040711 · MOB
Rhigene, Inc.
Immunology · 15d
Cleared Mar 22, 2004
BRAHMS DIAGNOSTICA LUMITEST TRAK HUMAN
K033454 · JZO
Brahms Diagnostica, LLC
Immunology · 144d
Cleared Mar 22, 2004
ZEUS SCIENTIFIC, INC., ATHENA MULTI-LYTE TPO/TG IGG TEST SYSTEM
K033977 · JZO
Zeus Scientific, Inc.
Immunology · 90d
Cleared Mar 22, 2004
MESACUP TEST MPO, MODEL 11053
K040586 · MOB
Rhigene, Inc.
Immunology · 17d
Cleared Mar 18, 2004
IMMULISA ANTI-SACCHAROMYCES CEREVISIAE ANTIBODY (ASCA) (IGG)
K032850 · NBT
Immco Diagnostics, Inc.
Immunology · 188d
Cleared Mar 18, 2004
IMMULISA ANTI-SACCHAROMYCES CEREVISIAE ANTIBODY (ASCA) (IGA)
K032860 · NBT
Immco Diagnostics, Inc.
Immunology · 188d
Cleared Mar 11, 2004
FREELITE HUMAN KAPPA AND LAMBDA KITS
K040009 · DFH
The Binding Site, Ltd.
Immunology · 69d
Cleared Mar 11, 2004
EL-ANA PROFILES: ANTI-CHROMATIN
K040291 · LJM
Theratest Laboratories, Inc.
Immunology · 34d
Cleared Mar 10, 2004
ROCHE DIAGNOSTICS TINA-QUANT IGM GEN.2
K040431 · DAO
Roche Diagnostics Corp.
Immunology · 20d
Cleared Mar 10, 2004
ROCHE DIAGNOSTICS TINA-QUANT IGG GEN.2
K040434 · DEW
Roche Diagnostics Corp.
Immunology · 20d
Cleared Mar 10, 2004
ROCHE DIAGNOSTICS TINA-QUANT IGA GEN.2
K040435 · CZP
Roche Diagnostics Corp.
Immunology · 20d