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
1417–1440 of 3,794
Search insights Median review: 63d Cleared: 100% Top manufacturer: Inova Diagnostics, Inc. Lead specialty: Immunology
Cleared Nov 13, 1997
VIRGO PANCO KIT
K973824 · MOB
Hemagen Diagnostics, Inc.
Immunology · 37d
Cleared Nov 10, 1997
IMX CA 15-3
K964407 · MOI
Abbott Laboratories
Immunology · 371d
Cleared Nov 10, 1997
APO-TEK LP(A)
K970302 · DFC
Perimmune, Inc.
Immunology · 287d
Cleared Nov 06, 1997
MONOCLONAL MOUSE ANTI-HUMAN CD30, KI-1 ANTIGEN, BER-H2 ANTIBODY FOR...
K965022 · DEH
Dako Corp.
Immunology · 325d
Cleared Nov 04, 1997
AXSYM CA 125
K964020 · LTK
Abbott Laboratories
Immunology · 393d
Cleared Nov 04, 1997
IMX CA 125
K964185 · LTK
Abbott Diagnostics
Immunology · 379d
Cleared Oct 31, 1997
CPA 125 II ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM
K964098 · LTK
Bayer Corp.
Immunology · 385d
Cleared Oct 31, 1997
TRUQUANT BR RIA
K965141 · MOI
Biomira USA, Inc.
Immunology · 312d
Cleared Oct 31, 1997
IMMULITE THIRD GENERATION PSA (LKUPI,LKUP5)
K972021 · LTJ
Diagnostic Products Corp.
Immunology · 151d
Cleared Oct 29, 1997
IMMUNOSCAN ANTI-GBM QUANTITATIVE KIT
K971464 · DBL
Euro-Diagnostica AB
Immunology · 190d
Cleared Oct 29, 1997
IMMUNOSCAN ANTI-MYELOPEROXIDASE ANTIBODIES (MPO-ANCA) QUANTITATIVE KIT
K971689 · MOB
Euro-Diagnostica AB
Immunology · 175d
Cleared Oct 29, 1997
IMMUNOSCAN PR3-ANCA
K971690 · MOB
Euro-Diagnostica AB
Immunology · 175d
Cleared Oct 29, 1997
ZEUS SCIENTIFIC, INC., ANTI-CARDIOLIPIN IGA ELISA REAGENTS
K973196 · MID
Zeus Scientific, Inc.
Immunology · 64d
Cleared Oct 22, 1997
VITROS IMMUNODIAGNOSTIC PRODUCTS FERRITIN REAGENT PACK (GEM.1340), FERRITIN...
K973331 · DBF
Ortho-Clinical Diagnostics, Inc.
Immunology · 48d
Cleared Oct 22, 1997
QUANTEX RF PLUS (LATEX, BUFFER, STANDARD, CONTROL)
K973464 · DHR
Instrumentation Laboratory CO
Immunology · 40d
Cleared Oct 20, 1997
VENTANA CD45 PRIMARY ANTIBODY
K940583 · DEH
Ventana Medical Systems, Inc.
Immunology · 1350d
Cleared Oct 20, 1997
N ANTISERUM TO HUMAN ALBUMIN
K972929 · DCF
Behring Diagnostics, Inc.
Immunology · 73d
Cleared Oct 20, 1997
QUANTA LITE B2 GPI IGA
K973006 · MSV
Inova Diagnostics, Inc.
Immunology · 68d
Cleared Oct 20, 1997
QUANTA LITE B2GPI IGM
K973014 · MSV
Inova Diagnostics, Inc.
Immunology · 68d
Cleared Oct 17, 1997
N ANTISERUM TO HUMAN TRANSFERRIN
K972840 · DDG
Behring Diagnostics, Inc.
Immunology · 77d
Cleared Oct 07, 1997
PRECINORM RF, PRECIPATH RF
K973629 · JJY
Boehringer Mannheim Corp.
Immunology · 13d
Cleared Oct 03, 1997
AIA-PACK IGE II ASSAY
K972697 · DGC
Tosoh Medics, Inc.
Immunology · 77d
Cleared Oct 03, 1997
CHEMMATE UCHL1 (CD45RO) PREDILUTED ANTIBODY FOR IMMUNOHISTOCHEMICAL STAINING
K973389 · DEM
Ventana Medical Systems, Inc.
Immunology · 85d
Cleared Oct 03, 1997
CHEMMATE L26 (CD20)
K973390 · DEM
Ventana Medical Systems, Inc.
Immunology · 85d