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
49–72 of 3,792
Search insights Median review: 63d Cleared: 100% Top manufacturer: Inova Diagnostics, Inc. Lead specialty: Immunology
Cleared Jan 24, 2024
Optilite® Freelite® Kappa Free Kit, Optilite® Freelite® Lambda Free Kit
K231290 · DFH
The Binding Site, Ltd.
Immunology · 265d
Cleared Dec 13, 2023
N Antisera to Human Immunoglobulins (IgG, IgA, and IgM)
K233663 · CFN
Siemens Healthcare Diagnostics...
Immunology · 28d
Cleared Nov 27, 2023
CardioPhase® hsCRP
K232624 · DCN
Siemens Healthcare Diagnostic...
Immunology · 90d
Cleared Nov 22, 2023
DxFLEX Flow Cytometer
K232600 · OYE
Beckman Coulter, Inc.
Immunology · 86d
Cleared Sep 30, 2023
Elecsys Tg II
K221890 · MSW
Roche Diagnostics
Immunology · 458d
Cleared Sep 29, 2023
TBI
K232669 · QAT
Abbott Laboratories
Immunology · 28d
Cleared Sep 29, 2023
Aptiva CTD Essential Reagent
K213403 · LLL
Inova Diagnostics, Inc.
Immunology · 711d
Cleared Sep 26, 2023
Access Thyroglobulin Antibody II
K213517 · JZO
Beckman Coulter, Inc.
Immunology · 692d
Cleared Sep 22, 2023
Access CEA
K223921 · DHX
Beckman Coulter, Inc.
Immunology · 267d
Cleared Sep 18, 2023
B·R·A·H·M·S CgA II KRYPTOR, B·R·A·H·M·S CgA II KRYPTOR CAL, B·R·A·H·M·S CgA...
K222251 · QXS
B.R.A.H.M.S GmbH, Part of Thermo Fisher
Immunology · 418d
Cleared Sep 15, 2023
Elecsys Anti-Tg
K222610 · JZO
Roche Diagnostics
Immunology · 382d
Cleared Sep 15, 2023
Access Thyroglobulin
K220972 · MSW
Beckman Coulter, Inc.
Immunology · 529d
Cleared Sep 08, 2023
IMMULITE/IMMULITE 1000 OM-MA, IMMULITE 2000 OM-MA
K213510 · LTK
Siemens Healthcare Diagnostics...
Immunology · 675d
Cleared Aug 31, 2023
ZEUS IFA(TM) nDNA Test System, ZEUS dIFine
K231616 · KTL
Zeus Scientific
Immunology · 90d
Cleared Aug 23, 2023
VITROS Immunodiagnostic Products CEA Reagent Pack
K231517 · DHX
Ortho-Clinical Diagnostics
Immunology · 90d
Cleared Aug 09, 2023
VITROS Immunodiagnostic Products CA 19-9TM Reagent Pack
K231525 · NIG
Ortho-Clinical Diagnostics
Immunology · 75d
Cleared Aug 02, 2023
Immunoglobulin G (IgG)
K221114 · CFN
Beckman Coulter Laboratory Systems...
Immunology · 474d
Cleared Jun 05, 2023
Elecsys ß-Amyloid (1-42) CSF II, Elecsys Total-Tau CSF
K231348 · QSE
Roche Diagnostics
Immunology · 27d
Cleared May 26, 2023
Image Navigator by Immuno Concepts, Immuno Concepts IgG Anti-nDNA Fluorescent...
K203599 · KTL
Immuno Concepts, N.A. , Ltd.
Immunology · 898d
Cleared Apr 13, 2023
ALPCO Calprotectin Immunoturbidimetric Assay
K220763 · NXO
ALPCO
Immunology · 393d
Cleared Mar 17, 2023
RCRP Flex reagent cartridge
K221119 · DCN
Siemens Healthcare Diagnostics, Inc.
Immunology · 333d
Cleared Mar 02, 2023
Traumatic brain injury (TBI) test
K223602 · QAT
Abbott Laboratories
Immunology · 90d
Cleared Feb 21, 2023
Quantia IgE
K214068 · DGC
Biokit, S.A.
Immunology · 421d
Cleared Dec 12, 2022
VITROS Immuodiagnostic Products CA 125 II Reagent Pack
K221355 · LTK
Ortho-Clinical Diagnostics
Immunology · 216d