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
1201–1224 of 3,794
Search insights Median review: 63d Cleared: 100% Top manufacturer: Inova Diagnostics, Inc. Lead specialty: Immunology
Cleared Mar 26, 1999
GLIADIN IGA ELISA TEST SYSTEM
K990207 · MST
Zeus Scientific, Inc.
Immunology · 64d
Cleared Mar 25, 1999
IGG FLEX REAGENT CARTRIDGE
K990551 · CFQ
Dade Behring, Inc.
Immunology · 31d
Cleared Mar 25, 1999
IMMUNOGLOBULIN A TEST SYSTEM
K990552 · CFQ
Dade Behring, Inc.
Immunology · 31d
Cleared Mar 25, 1999
VITROS IMMUNODIAGNOSTIC PRODUCTS CA15-3 RANGE VERIFIERS, CA125 II RANGE...
K990783 · JJX
Ortho-Clinical Diagnostics, Inc.
Immunology · 16d
Cleared Mar 22, 1999
IGM FLEX REAGENT CARTRIDGE
K990553 · CFQ
Dade Behring, Inc.
Immunology · 28d
Cleared Mar 22, 1999
DIMENSION SPECIAL PROTEIN CALIBRATOR
K990554 · JIT
Dade Behring, Inc.
Immunology · 28d
Cleared Mar 18, 1999
ACL/APS FACS KIT
K984102 · MID
Louisville Apl Diagnostics, Inc.
Immunology · 121d
Cleared Mar 12, 1999
IMMULITE THYROGLOBULIN MODEL LKTY
K982466 · MSW
Diagnostic Products Corp.
Immunology · 240d
Cleared Mar 12, 1999
IMMULITE 2000 THYROGLOBULIN MODEL L2KTY
K982468 · MSW
Diagnostic Products Corp.
Immunology · 240d
Cleared Mar 12, 1999
VITROS IMMUNODIAGNOSTIC PRODUCTS PSA CALIBRATORS, VITROS IMMUNODIAGNOSTIC...
K984289 · LTJ
Ortho-Clinical Diagnostics, Inc.
Immunology · 101d
Cleared Mar 08, 1999
RF
K990035 · DHR
Abbott Laboratories
Immunology · 61d
Cleared Feb 23, 1999
BINDING SITE BINDAZYME ANTI-GBM EIA DIAGNOSTIC TEST KIT
K984619 · MVJ
The Binding Site, Ltd.
Immunology · 56d
Cleared Feb 17, 1999
GLIADIN ANTIBODIES ELISA
K973910 · MST
Genesis Diagnostics , Ltd.
Immunology · 491d
Cleared Feb 08, 1999
ELECYS IGE ASSAY
K984326 · JHR
Boehringer Mannheim Corp.
Immunology · 67d
Cleared Feb 08, 1999
QUANTA LITE GBM ELISA
K984336 · MVJ
Inova Diagnostics, Inc.
Immunology · 67d
Cleared Feb 05, 1999
ANTICARDIOLIPIN IGG SCREEN EIA DIAGNOSTIC TEST
K983692 · MID
The Binding Site, Ltd.
Immunology · 107d
Cleared Feb 05, 1999
ANTICARDIOLIPIN IGM SCREEN EIA DIAGNOSTIC TEST KIT
K983694 · MID
The Binding Site, Ltd.
Immunology · 107d
Cleared Feb 05, 1999
ANTICARDIOLIPIN IGGAM SCREEN EIA DIAGNOSTIC TEST KIT
K983695 · MID
The Binding Site, Ltd.
Immunology · 107d
Cleared Feb 05, 1999
ANTICARDIOLIPIN IGA SCREEN EIA DIAGNOSTIC TEST KIT
K983696 · MID
The Binding Site, Ltd.
Immunology · 107d
Cleared Feb 02, 1999
VITROS IMMUNODIAGNOSTIC PRODUCTS CA 15-3 CALIBRATORS,VITROS IMMUNODIAGNOSTIC...
K983690 · MOI
Ortho-Clinical Diagnostics, Inc.
Immunology · 104d
Cleared Feb 02, 1999
ANTI-TPO EIA DIAGNOSTIC TEST KIT
K984163 · JZO
The Binding Site, Ltd.
Immunology · 74d
Cleared Feb 02, 1999
ANTI-THYROGLOBULIN EIA DIAGNOSTIC TEST KIT
K984165 · JZO
The Binding Site, Ltd.
Immunology · 74d
Cleared Feb 02, 1999
NICHOLS ADVANTAGE CHEMILUMINESCENCE FERRITIN IMMUNOASSAY
K984186 · DBF
Nichols Institute Diagnostics
Immunology · 71d
Cleared Feb 02, 1999
IS ANTI-TPO IGG ELISA TEST SYSTEM
K984228 · JZO
Columbia Bioscience, Inc.
Immunology · 69d