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
745–768 of 3,792
Search insights Median review: 63d Cleared: 100% Top manufacturer: Inova Diagnostics, Inc. Lead specialty: Immunology
Cleared Sep 09, 2003
IMMULISA ANTI-BETA2 GLYCOPROTEIN I (B2GP1) IGG ELISA
K030701 · MSV
Immco Diagnostics, Inc.
Immunology · 187d
Cleared Sep 09, 2003
IMMULISA ANTI-BETA2 GLYCOPROTEIN I (B2GP1) IGM ELISA
K030702 · MSV
Immco Diagnostics, Inc.
Immunology · 187d
Cleared Sep 05, 2003
N/T PROTEIN CONTROL
K032237 · JJY
Dade Behring, Inc.
Immunology · 46d
Cleared Aug 29, 2003
IBL C1Q-CIC CIA TEST
K032254 · DAK
Ibl GmbH
Immunology · 38d
Cleared Aug 07, 2003
N LATEX IGM
K032014 · CFN
Dade Behring, Inc.
Immunology · 38d
Cleared Aug 07, 2003
SYNCHRON LX SYSTEMS COMPLEMENT C3 (C3) REAGENT, SYNCHRON LX SYSTEMS...
K032035 · CZW
Beckman Coulter, Inc.
Immunology · 37d
Cleared Jul 23, 2003
LINICAL PROTEIN 2 CALIBRATION VERIFIERS LEVELS A-E FOR OLYMPUS AU ANALYZERS
K031575 · JJY
Cliniqa Corporation
Immunology · 64d
Cleared Jul 17, 2003
FERRITIN GENERATION 2
K031650 · DBF
Roche Diagnostics Corp.
Immunology · 50d
Cleared Jul 15, 2003
FREELITE HUMAN KAPPA AND LAMBDA FREE KITS FOR USE ON THE DAD BEHRING...
K031016 · DEH
The Binding Site, Ltd.
Immunology · 106d
Cleared Jul 07, 2003
REAADS IGM ANTI-B2GPI TEST KIT, MODEL 038-001
K031208 · MSV
Corgenix, Inc.
Immunology · 81d
Cleared Jun 25, 2003
QUANTA PLEX ENA PROFILE 6
K031450 · LLL
Inova Diagnostics, Inc.
Immunology · 49d
Cleared Jun 24, 2003
BAYER ADVIA CENTAUR CA 19-9 ASSAY
K031393 · NIG
Bayer Healthcare, LLC
Immunology · 53d
Cleared Jun 19, 2003
DIASTAT ANTI-B2 GLYCOPROTEIN 1 IGM, MODEL FBGP 100M
K031177 · MSV
Axis-Shield Diagnostics, Ltd.
Immunology · 66d
Cleared Jun 02, 2003
CRP-LATEX (II)X2 SEIKEN ASSAY KIT
K030545 · DCK
Denka Seiken Co., Ltd.
Immunology · 102d
Cleared Jun 02, 2003
CRP (II) CALIBRATORS
K030546 · JIS
Denka Seiken Co., Ltd.
Immunology · 102d
Cleared May 15, 2003
TPSA FLEX REAGENT CARTRIDGE
K031343 · LTJ
Dade Behring, Inc.
Immunology · 16d
Cleared May 12, 2003
AUTO I.D. JO-1, SCL-70 & PCNA POSITIVE CONTROL SERUM
K030775 · LKJ
Immuno Concepts, N.A. , Ltd.
Immunology · 62d
Cleared May 06, 2003
ACCESS CEA REAGENTS FOR USE ON THE ACCESS IMMUNOASSAY SYSTEMS
K031270 · DHX
Beckman Coulter, Inc.
Immunology · 15d
Cleared May 02, 2003
ANA DETECT
K030929 · LJM
Orgentec Diagnostika GmbH
Immunology · 39d
Cleared May 02, 2003
ACCESS THYROGLOBULIN REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS
K031269 · MSW
Beckman Coulter, Inc.
Immunology · 11d
Cleared May 02, 2003
ACCESS OV MONITOR ASSAY
K031297 · LTK
Beckman Coulter, Inc.
Immunology · 8d
Cleared May 01, 2003
AUTOSTAT II ANTI-CARDIOLIPIN IGA ELISA
K030741 · MID
Hycor Biomedical , Ltd.
Immunology · 52d
Cleared Apr 24, 2003
QUANTA PLEX ENA PROFILE 5
K030681 · LLL
Inova Diagnostics, Inc.
Immunology · 50d
Cleared Apr 21, 2003
IBD-QUIK CHEK
K030704 · DEG
Techlab, Inc.
Immunology · 46d