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
193–216 of 3,792
Search insights Median review: 63d Cleared: 100% Top manufacturer: Inova Diagnostics, Inc. Lead specialty: Immunology
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
Cleared Jul 28, 2016
AESKUSLIDES ANA HEp-2-Gamma, HELIOS FULLY AUTOMATED IFA SYSTEM
K153117 · DHN
Aesku Systems GmbH&Co.Kg
Immunology · 274d
Cleared Jul 28, 2016
ImmunoCAP Total IgE Calibrator Strip/Total IgE Curve Control Strip, ImmunoCAP...
K161899 · DGC
Phadia AB
Immunology · 17d