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
961–984 of 3,794
Search insights Median review: 63d Cleared: 100% Top manufacturer: Inova Diagnostics, Inc. Lead specialty: Immunology
Cleared Apr 05, 2001
IMMAGE IMMUNOCHEMISTRY SYSTEM HIGH SENSITIVITY C-REACTIVE PROTEIN (CRPH) REAGENT
K010236 · DCK
Beckman Coulter, Inc.
Immunology · 70d
Cleared Apr 03, 2001
QUANTA LITE GPA (GASTRIC PARIETAL CELL ANTIBODY) ELISA
K010558 · MLE
Inova Diagnostics, Inc.
Immunology · 36d
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