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
1417–1440 of 3,792
Search insights Median review: 63d Cleared: 100% Top manufacturer: Inova Diagnostics, Inc. Lead specialty: Immunology
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
Cleared Oct 03, 1997
CHEMMATE KAPPA
K973391 · DEM
Ventana Medical Systems, Inc.
Immunology · 85d
Cleared Oct 03, 1997
CHEMMATE LAMBDA
K973392 · DEM
Ventana Medical Systems, Inc.
Immunology · 86d