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
169–192 of 3,794
Search insights Median review: 63d Cleared: 100% Top manufacturer: Inova Diagnostics, Inc. Lead specialty: Immunology
Cleared Jun 04, 2018
BUHLMANN fCAL ELISA
K181012 · NXO
Buhlmann Laboratories AG
Immunology · 48d
Cleared May 24, 2018
EUROIMMUN IFA Granulocyte Mosaic™ EUROPattern and EUROIMMUN EUROPLUS...
K172582 · MOB
Euroimmun Us, Inc.
Immunology · 269d
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