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
865–888 of 3,792
Search insights Median review: 63d Cleared: 100% Top manufacturer: Inova Diagnostics, Inc. Lead specialty: Immunology
Cleared May 16, 2002
QACA IGG/IGM ELISA KIT HRP
K021192 · MID
Cheshire Diagnostics , Ltd.
Immunology · 31d
Cleared May 14, 2002
PELICLASS HUMAN IGG SUBCLASS NEPHELOMETRIC IMMAGE KIT
K020823 · DFZ
Sanquin Blood Supply Foundation
Immunology · 61d
Cleared May 09, 2002
FUJIREBIO DIAGNOSTICS CA 19-9 RIA
K020566 · NIG
Fujirebio Diagnostics,Inc.
Immunology · 78d
Cleared May 02, 2002
ABBOTT AXSYM ANTI-THYROID-PEROXIDASE, MODELS5F57 COMPRISING...
K020348 · JZO
Axis-Shield Diagnostics, Ltd.
Immunology · 87d
Cleared May 02, 2002
ABBOTT AXSYM ANTI-THYROGLOBULIN, MODELS 5F5B COMPRISING STANDARD/CALIBRATORS
K020349 · JZO
Axis-Shield Diagnostics, Ltd.
Immunology · 87d
Cleared May 02, 2002
DIASTAT ANTI-THYROID PEROXIDASE ELISA MODEL #300
K020687 · JZO
Axis-Shield Diagnostics, Ltd.
Immunology · 59d
Cleared May 02, 2002
VARELISA CARDIOLIPIN IGG ANTIBODIES, MODELS 15548 & 15596
K020752 · MID
Pharmacia Deutschland GmbH
Immunology · 56d
Cleared May 02, 2002
VARELISA CARDIOLIPIN IGA ANTIBODIES, MODELS 15748 & 15796
K020757 · MID
Pharmacia Deutschland GmbH
Immunology · 56d
Cleared May 02, 2002
VARELISA CARDIOLIPIN IGM ANTIBODIES, MODELS 15648 & 15696
K020758 · MID
Pharmacia Deutschland GmbH
Immunology · 56d
Cleared Apr 29, 2002
QUANTA LITE CCP ELISA
K020414 · NHX
Inova Diagnostics, Inc.
Immunology · 81d
Cleared Apr 24, 2002
MODIFICATION TO ZEUS SCIENTIFIC'S ATHENA MULTI-LYTE ANA TEST SYSTEM
K021103 · LKJ
Zeus Scientific, Inc.
Immunology · 19d
Cleared Apr 19, 2002
QAB2A IGM ELISA KIT
K020694 · MVS
Cheshire Diagnostics , Ltd.
Immunology · 46d
Cleared Apr 19, 2002
QAB2A IGG ELISA KIT
K020695 · MSV
Cheshire Diagnostics , Ltd.
Immunology · 46d
Cleared Apr 17, 2002
MYALLERGYTEST SYSTEM
K020387 · DHB
Immunetech Corporation
Immunology · 71d
Cleared Apr 11, 2002
RHIGENE NDNA TEST SYSTEM FOR IMAGETITER, MODEL CL100L
K011068 · KTL
Rhigene, Inc.
Immunology · 367d
Cleared Mar 28, 2002
IMMULITE BR-MA, MODEL #LKBR
K013984 · MOI
Diagnostic Products Corp.
Immunology · 115d
Cleared Mar 27, 2002
ACS:180 & ADVIA CENTAUR AFP IMMUNOASSAY
K020806 · LOJ
Bayer Corp.
Immunology · 15d
Cleared Mar 13, 2002
QACA IGG/IGM ELISA KIT
K020241 · MID
Cheshire Diagnostics , Ltd.
Immunology · 49d
Cleared Mar 06, 2002
DIASTAT TOTAL ANTI-CARDIOLIPIN, MODEL FCAR 100T
K020156 · MID
Axis-Shield Diagnostics, Ltd.
Immunology · 48d
Cleared Mar 06, 2002
ELECSYS ANTI-TG CALCHECK
K020369 · JJX
Roche Diagnostics Corp.
Immunology · 30d
Cleared Feb 28, 2002
CA 15-3 ASSAY FOR THE ADVIA CENTAUR SYSTEM
K012357 · MOI
Bayer Diagnostics Corp.
Immunology · 218d
Cleared Feb 22, 2002
TORFLEX TRANSSEPTAL GUIDING SHEATH
K013919 · DBY
Baylis Medical Co., Inc.
Immunology · 87d
Cleared Feb 19, 2002
K-ASSAY FERRITIN, K-ASSAY FERRITIN CALIBRATOR SET
K014293 · DBF
Kamiya Biomedical Co.
Immunology · 53d
Cleared Feb 08, 2002
UROVYSION BLADDER CANCER RECURRENCE KIT
K013785 · MMW
Vysis
Immunology · 86d