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
961–984 of 3,792
Search insights Median review: 63d Cleared: 100% Top manufacturer: Inova Diagnostics, Inc. Lead specialty: Immunology
Cleared Mar 30, 2001
REAADS IGM ANTI-PROTHROMBIN SEMI-QUANTITATIVE TEST KIT
K001398 · DHC
Corgenix, Inc.
Immunology · 331d
Cleared Mar 28, 2001
ELECSYSCA 15-3 II ASSAY
K010588 · MOI
Roche Diagnostics Corp.
Immunology · 29d
Cleared Mar 19, 2001
C1-INHIBITOR MICROTITER ASSAY DEVICE
K003747 · DBA
Baxter Healthcare Corp
Immunology · 105d
Cleared Mar 16, 2001
SCIMEDX PHASE II PR3 IGG ANTIBODY EIA
K010287 · MOB
Scimedx Corp.
Immunology · 44d
Cleared Mar 15, 2001
SPIFE IFE CALIBRATOR AND CONTROL KIT
K010617 · DEW
Helena Laboratories
Immunology · 14d
Cleared Mar 07, 2001
SCIMEDX PHASE II MPO IGG ANTIBODY EIA
K010289 · MOB
Scimedx Corp.
Immunology · 35d
Cleared Mar 05, 2001
VIGIL SEROLOGY CONTROL LEVEL C
K010358 · JJY
Beckman Coulter, Inc.
Immunology · 27d
Cleared Mar 01, 2001
ENA EIA KIT RANGE
K010146 · LLL
The Binding Site, Ltd.
Immunology · 43d
Cleared Mar 01, 2001
ENA EIA KIT
K010147 · LLL
The Binding Site, Ltd.
Immunology · 43d
Cleared Feb 28, 2001
DIMENSION PSA FLEX REAGENT CARTRIDGE
K003963 · LTJ
Dade Behring, Inc.
Immunology · 68d
Cleared Feb 23, 2001
ENA SCREEN EIA KIT
K010148 · LLL
The Binding Site, Ltd.
Immunology · 37d
Cleared Feb 15, 2001
ANA EIA DIAGNOSTIC TEST KIT
K004019 · LJM
The Binding Site, Ltd.
Immunology · 50d
Cleared Feb 14, 2001
RCRP FLEX REAGENT CARTRIDGE
K003419 · DCN
Dade Behring, Inc.
Immunology · 104d
Cleared Feb 01, 2001
KAPPA IMMAGE FREELITE KIT
K003669 · DFH
The Binding Site, Ltd.
Immunology · 65d
Cleared Feb 01, 2001
LAMBDA IMMAGE FREELITE KIT
K003671 · DEH
The Binding Site, Ltd.
Immunology · 65d
Cleared Jan 22, 2001
QUANTA LITE CENTROMERE (CENP-A & CENP-B) ELISA
K003959 · LJM
Inova Diagnostics, Inc.
Immunology · 32d
Cleared Jan 12, 2001
CA 125 II CALCHECK
K003967 · JJX
Roche Diagnostics Corp.
Immunology · 21d
Cleared Jan 12, 2001
ELECSYS CA 125 II CALSET
K003969 · JIS
Roche Diagnostics Corp.
Immunology · 21d
Cleared Dec 26, 2000
IMMULITE HIGH SENSITIVITY CRP, IMMULITE 2000 HIGH SENSITIVITY CRP
K003372 · DCN
Diagnostic Products Corp.
Immunology · 57d
Cleared Dec 05, 2000
BAYER DIAGNOSTICS ACS:180 AND ADVIA CENTAUR ANTI-TPO ASSAY
K003291 · JZO
Bayer Diagnostics Corp.
Immunology · 46d
Cleared Nov 30, 2000
FASTPACK CALIBRATORS
K003096 · JIT
Qualigen, Inc.
Immunology · 58d
Cleared Nov 29, 2000
FASTPACK CONTROL
K003095 · JJX
Qualigen, Inc.
Immunology · 57d
Cleared Nov 27, 2000
ANTI-CARDIOLIPIN, MULTIPLE AUTOANTIBODIES IMMUNOLOGICAL TEST SYSTEM
K003069 · MID
Quest Intl., Inc.
Immunology · 56d
Cleared Nov 27, 2000
VARELISA TG (THYROGLOBULIN) ANTIBODIES,
K003414 · JZO
Pharmacia & Upjohn Co.
Immunology · 25d