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
865–888 of 3,794
Search insights Median review: 63d Cleared: 100% Top manufacturer: Inova Diagnostics, Inc. Lead specialty: Immunology
Cleared May 30, 2002
IMMULITE 2000 SPECIFIC ALLERGENS
K021206 · DHB
Diagnostic Products Corp.
Immunology · 44d
Cleared May 30, 2002
IMMULITE 2000 MIXED ALLERGEN PANELS
K021208 · DHB
Diagnostic Products Corp.
Immunology · 44d
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