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
49–72 of 3,794
Search insights Median review: 63d Cleared: 100% Top manufacturer: Inova Diagnostics, Inc. Lead specialty: Immunology
Cleared Feb 23, 2024
FLC Kappa, FLC Lambda,FLC Control Level 1, FLC Control Level 2
K231601 · DFH
Sebia
Immunology · 267d
Cleared Feb 06, 2024
BÜHLMANN fCAL® turbo and CALEX® Cap
K232057 · NXO
B?hlmann Laboratories AG
Immunology · 210d
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