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
697–720 of 3,792
Search insights Median review: 63d Cleared: 100% Top manufacturer: Inova Diagnostics, Inc. Lead specialty: Immunology
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
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