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
649–672 of 3,792
Search insights Median review: 63d Cleared: 100% Top manufacturer: Inova Diagnostics, Inc. Lead specialty: Immunology
Cleared Jun 13, 2005
QUANTA LITE SP100 ELISA
K050662 · NUM
Inova Diagnostics, Inc.
Immunology · 90d
Cleared Jun 09, 2005
MODIFICATION TO: UNICAP SPECIFIC IGE
K051218 · DHB
Pharmacia Diagnostics AB
Immunology · 28d
Cleared Jun 01, 2005
AESKULISA TTG A AND AESKULISA TTG G
K042644 · MVM
Aesku, Inc.
Immunology · 247d
Cleared May 31, 2005
ENA IGG BEADCHIP TEST SYSTEM, ARRAY IMAGING SYSTEM, MODELS 800-00025, AIS 400
K043067 · LLL
Bioarray Solutions, Ltd.
Immunology · 204d
Not Cleared May 19, 2005
LBA AFP-L3, AFP-L3 CALIBRATOR SET, AFP-L3 CONTROL SET AND LIBASYS
DEN050002 · NSF
Wako Chemicals USA, Inc.
Immunology · 42d
Cleared May 13, 2005
QUANTIA A1-AT
K050596 · DEM
Biokit, S.A.
Immunology · 66d
Cleared May 12, 2005
QUANTA PLEX ANCA PROFILE
K050715 · MOB
Inova Diagnostics, Inc.
Immunology · 55d
Cleared May 06, 2005
PARAGON CZE 2000 URINE PROTEIN ELECTROPHORESIS KIT AND URINE IMMUNOFIXATION...
K050119 · JKM
Beckman Coulter, Inc.
Immunology · 108d
Cleared May 02, 2005
N ANTISERA TO HUMAN COMPLEMENT FACTORS (C3C, C4)
K050665 · CZW
Dade Behring, Inc.
Immunology · 48d
Cleared Apr 26, 2005
VARELISA RECOMBI ANA PROFILE, MODEL 18496
K050625 · LJM
Sweden Diagnostics (Germany) GmbH
Immunology · 46d
Cleared Apr 25, 2005
ROCHE DIAGNOSTICS ELECSYS PRECICONTROL TUMOR
K050387 · JJY
Roche Diagnostics Corp.
Immunology · 69d
Cleared Mar 07, 2005
AUTOSTAT II ANTI-TISSUE TRANSGLUTAMINASE IGG ELISA
K043433 · MVM
Hycor Biomedical , Ltd.
Immunology · 84d
Cleared Feb 28, 2005
ACON MONONUCLEOSIS RAPID TEST STRIP (WHOLE BLOOD/SERUM/PLASMA)
K042272 · KTN
ACON Laboratories, Inc.
Immunology · 189d
Cleared Feb 15, 2005
N ANTISERA TO HUMAN IMMUNOGLOBULINS (IGG, IGA AND IGM)
K042735 · CFN
Dade Behring, Inc.
Immunology · 137d
Cleared Feb 08, 2005
TINA-QUANT IGG GEN.2
K050113 · DEW
Roche Diagnostics Corp.
Immunology · 21d
Cleared Dec 22, 2004
ARCHITECT CA 15-3 ASSAY
K042732 · MOI
Fujirebio Diagnostics,Inc.
Immunology · 82d
Cleared Dec 20, 2004
BIOPLEX 200 ANA SCREEN ON THE BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM,...
K041658 · LKJ
Bio-Rad Laboratories, Inc.
Immunology · 185d
Cleared Dec 17, 2004
KRONUS, INC.'S ACETYLCHOLINE RECEPTOR ANTIBODY (ACHRAB) ASSAY KIT
K042248 · NST
Kronus Market Development Associates,...
Immunology · 120d
Cleared Dec 10, 2004
K-ASSAY TOTAL IGE, K-ASSAY IGE CALIBRATOR SET, MODELS KAI-092/KAI-093C
K042241 · DGC
Kamiya Biomedical Co.
Immunology · 113d
Cleared Dec 08, 2004
VARELISA SM ANTIBODIES, MODEL 18296
K042629 · LKP
Sweden Diagnostics (Germany) GmbH
Immunology · 72d
Cleared Dec 07, 2004
LIQUICHEK SPECIALTY IMMUNOASSAY CONTROL
K043108 · JJY
Bio-Rad Laboratories, Inc.
Immunology · 28d
Cleared Nov 23, 2004
ROCHE DIAGNOSTICS ELECSYS AFP CALSET II
K043095 · JIT
Roche Diagnostics Corp.
Immunology · 14d
Cleared Nov 22, 2004
BINDING SITE IGG SUBLCASS OLYMPUS KITS
K042152 · CFN
The Binding Site
Immunology · 105d
Cleared Nov 19, 2004
RHIGENE HEP-ANA TEST SYSTEM
K042680 · DHN
Corgenix, Inc.
Immunology · 51d