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
649–672 of 3,794
Search insights Median review: 63d Cleared: 100% Top manufacturer: Inova Diagnostics, Inc. Lead specialty: Immunology
Cleared Jun 28, 2005
VARELISA RECOMBI CTD SCREEN, MODEL 13096
K050967 · LJM
Sweden Diagnostics (Germany) GmbH
Immunology · 71d
Cleared Jun 27, 2005
CAPILLARY'S IMMUNOTYPING (PN 2100)
K042939 · DFH
Sebia, Inc.
Immunology · 245d
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