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
1201–1224 of 3,792
Search insights Median review: 63d Cleared: 100% Top manufacturer: Inova Diagnostics, Inc. Lead specialty: Immunology
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
Cleared Feb 02, 1999
ELECSYS IGE CALCHECK
K984419 · JJY
Boehringer Mannheim Corp.
Immunology · 54d
Cleared Jan 29, 1999
APOLIPOPROTEIN A1
K983289 · DER
Abbott Laboratories
Immunology · 133d