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
193–216 of 3,794
Search insights Median review: 63d Cleared: 100% Top manufacturer: Inova Diagnostics, Inc. Lead specialty: Immunology
Cleared Jul 03, 2017
BD FACSLyric Flow Cytometer (3-1, 4-2, 4-2-2 and 4-3-3 optical...
K170974 · OYE
Becton, Dickinson and Company
Immunology · 91d
Not Cleared Jun 29, 2017
ClearLLab T1, ClearLLab T2, ClearLLab B1, ClearLLab B2, ClearLLab M
DEN160047 · PWD
Beckman Coulter
Immunology · 269d
Cleared Jun 23, 2017
Navios EX Flow Cytometer, 6 Color/2 Laser, Navios EX Flow Cytometer, 8...
K162897 · OYE
Beckman Coulter
Immunology · 249d
Cleared Jun 22, 2017
TransFix/EDTA Vacuum Blood Collection Tubes
K162723 · GIM
Caltag Medsystems, Ltd.
Immunology · 266d
Cleared Jun 19, 2017
ImmuLisa Enhanced B2GP1 IgA Antibody ELISA, ImmuLisa Enhanced B2GP1 IgG...
K162788 · MSV
Immco Diagnostics, Inc.
Immunology · 259d
Cleared May 17, 2017
FREND PSA PLUS (reagent cartridge)
K162378 · LTJ
Nanoentek USA, Inc.
Immunology · 266d
Cleared May 05, 2017
ImmunoCAP Allergen w1, Common ragweed
K163370 · DHB
Phadia AB
Immunology · 155d
Cleared May 03, 2017
Optilite Rheumatoid Factor Kit
K162263 · DHR
The Binding Site Group , Ltd.
Immunology · 265d
Cleared Apr 05, 2017
C-Reactive Protein Kit for use on SPAPLUS
K161982 · DCN
The Binding Site Group
Immunology · 260d
Cleared Mar 10, 2017
Audit MicroControls Linearity FD Tumor Markers II
K163629 · JJY
Aalto Scientific, Ltd.
Immunology · 78d
Cleared Mar 02, 2017
Dextramer CMV Kit
K153538 · GKZ
Immudex Aps
Immunology · 448d
Cleared Feb 03, 2017
NOVA Lite DAPI ANCA Ethanol Kit, NOVA Lite DAPI ANCA Formalin Kit
K161258 · MOB
Inova Diagnostics, Inc.
Immunology · 275d
Cleared Jan 12, 2017
Elecsys CYFRA 21-1 CalCheck 5
K162173 · JJX
Roche Diagnostics
Immunology · 162d
Cleared Jan 10, 2017
Liquichek Tumor Marker Control-Level 1
K163015 · JJY
Bio-Rad Laboratories
Immunology · 74d
Cleared Jan 09, 2017
Ceruloplasmin
K161508 · DDB
Beckman Coulter Ireland, Inc.
Immunology · 222d
Cleared Jan 09, 2017
DxC 700 AU Clinical Chemistry Analyzer, AU IgG Reagent
K162208 · CFN
Beckman Coulter, Inc.
Immunology · 157d
Cleared Dec 21, 2016
CAPI 3 IMMUNOTYPING, CAPILLARYS 3 TERA, IT/IF CONTROL
K161928 · CFF
Sebia
Immunology · 160d
Cleared Dec 14, 2016
Elecsys CYFRA 21-1, Elecsys CYFRA 21-1 CalSet, PreciControl Tumor Marker
K160915 · OVK
Roche Diagnostics
Immunology · 257d
Cleared Dec 07, 2016
Rheumatoid Factor (RF) Kit for use on SPAPLUS
K160070 · DHR
The Binding Site Group , Ltd.
Immunology · 329d
Cleared Nov 18, 2016
Diazyme Human Kappa Free Light Chain Assay, Diazyme Human Lambda Free Light...
K153394 · DFH
Diazyme Laboratories
Immunology · 360d
Cleared Nov 10, 2016
Calprest NG
K160447 · NXO
Eurospital S.P.A.
Immunology · 267d
Cleared Oct 04, 2016
Hevylite Human IgG Kappa Kit for use on the SPAPLUS, Hevylite Human IgG...
K161854 · PCN
The Binding Site Group , Ltd.
Immunology · 90d
Cleared Aug 25, 2016
Optilite Low Level Albumin Kit
K153560 · DCF
The Binding Site Group , Ltd.
Immunology · 255d
Cleared Aug 04, 2016
ADVIA Centaur Anti-CCP IgG (aCCP) assay including Reagents and Calibrators,...
K153551 · NHX
Axis-Shield Diagnostics Limited
Immunology · 237d