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
169–192 of 3,792
Search insights Median review: 63d Cleared: 100% Top manufacturer: Inova Diagnostics, Inc. Lead specialty: Immunology
Cleared Apr 20, 2018
EUROIMMUN IFA: Crithidia luciliae (anti-dsDNA) EUROPattern
K172244 · KTL
Euroimmun Us, Inc.
Immunology · 268d
Cleared Apr 20, 2018
EUROIMMUN IFA: Crithidia luciliae sensitive (anti-dsDNA) EUROPattern
K172252 · KTL
Euroimmun Us, Inc.
Immunology · 268d
Cleared Apr 16, 2018
ImmunoCAP Specific IgE, ImmunoCAP Allergen f447, Allergen Component rAra h 6,...
K173726 · DHB
Phadia AB
Immunology · 132d
Cleared Mar 30, 2018
ImmuLisa Enhanced RNA POL III Antibody ELISA
K172078 · NYO
Immco Diagnostics, Inc.
Immunology · 263d
Cleared Mar 23, 2018
AESKUSLIDES ANCA Ethanol, AESKUSLIDES ANCA Formalin
K172461 · MOB
Aesku.Diagnostics GmbH & Co. KG
Immunology · 221d
Cleared Mar 13, 2018
EliA PR3s Immunoassay
K173792 · MOB
Phadia AB
Immunology · 89d
Cleared Mar 02, 2018
ImmunoCAP Tryptase, ImmunoCAP Tryptase Calibrators, ImmunoCAP Tryptase Curve...
K173704 · OYL
Phadia AB
Immunology · 88d
Cleared Feb 28, 2018
Optilite C-Reactive Protein Reagent,Optilite C-Reactive Protein...
K172868 · DCN
The Binding Site Group , Ltd.
Immunology · 161d
Cleared Feb 20, 2018
Elecsys CA 15-3 II
K171605 · MOI
Roche Diagnostics
Immunology · 264d
Cleared Feb 16, 2018
AESKUSLIDES nDNA (Crithidia luciliae), AESKUSLIDES nDNA (Crithidia luciliae)...
K172348 · LSW
Aesku.Diagnostics GmbH & Co. KG
Immunology · 197d
Cleared Feb 15, 2018
Optilite Hevylite IgG Kappa Kit, Optilite Hevylite IgG Lambda Kit
K172613 · PCN
The Binding Site Group , Ltd.
Immunology · 168d
Not Cleared Feb 14, 2018
Banyan BTI
DEN170045 · QAT
Banyan Biomarkers, Inc.
Immunology · 170d
Cleared Jan 12, 2018
MSD CRP Assay Kit and MESO SECTOR S 700 Instrument
K171498 · DCN
Meso Scale Diagnostics, LLC
Immunology · 234d
Cleared Jan 11, 2018
HYDRASHIFT 2/4 daratumumab, daratumumab Control
K172195 · CFF
Sebia
Immunology · 174d
Cleared Dec 22, 2017
QUANTA Flash Calprotectin Reagents, QUANTA Flash Calprotectin Calibrators,...
K170993 · NXO
Inova Diagnostics, Inc.
Immunology · 263d
Cleared Nov 17, 2017
N Latex FLC kappa assay, N Latex FLC Lambda assay, N FLC Standard SL, N FLC...
K171742 · DFH
Siemens Healthcare Diagnostics...
Immunology · 158d
Cleared Nov 11, 2017
A1AT Genotyping Test
K171868 · PZH
Progenika Biopharma S.A., A Grifols...
Immunology · 142d
Cleared Sep 06, 2017
QUANTA Flash® LKM-1 Reagents, QUANTA Flash® LKM-1 Calibrators, QUANTA Flash®...
K163538 · NBS
Inova Diagnostics, Inc.
Immunology · 264d
Cleared Sep 05, 2017
QUANTA Flash M2 (MIT3), QUANTA Flash M2 (MIT3) Calibrators, QUANTA Flash M2...
K163525 · DBM
Inova Diagnostics, Inc.
Immunology · 264d
Cleared Aug 31, 2017
Atellica IM Ferritin Assay
K171642 · DBF
Siemens Healthcare Diagnostics, Inc.
Immunology · 90d
Cleared Aug 08, 2017
ImmuLisa Enhanced AMA IgG Antibody ELISA
K163133 · DBM
Immco Diagnostics, Inc.
Immunology · 273d
Cleared Jul 28, 2017
ImmuLisa Enhanced Gliadin IgA Antibody ELISA, ImmuLisa Enhanced Gliadin IgG...
K163177 · MST
Immco Diagnostics, Inc.
Immunology · 256d
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