FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ 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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Pathology ×
1,109 results
73–96 of 1,109
Search insights Median review: 34d Cleared: 98% Top manufacturer: J R Scientific Lead specialty: Pathology
Cleared Dec 22, 2017
MRDx BCR-ABL Test, MRDx BCR-ABL Test Software
K173492 · OYX
MolecularMD Corporation
Pathology · 39d
Cleared Dec 21, 2017
FLEX Monoclonal Mouse Anti-Human Progesterone Receptor, Clone PgR 1294,...
K170005 · MXZ
Dako Denmark A/S
Pathology · 352d
Cleared Dec 21, 2017
FLEX Monoclonal Rabbit Anti-Human Estrogen Receptor a, Clone EPI, RTU (Dako...
K170028 · MYA
Dako Denmark A/S
Pathology · 352d
Cleared Dec 21, 2017
MMPC-4127F1
K172922 · PZZ
Barco N.V.
Pathology · 87d
Not Cleared Nov 15, 2017
MSK-IMPACT (Integrated Mutation Profiling of Actionable Cancer Targets):a...
DEN170058 · PZM
Memorial Sloan-Kettering Cancer Center
Pathology · 51d
Not Cleared Oct 27, 2017
VENTANA anti-MLH-1(M1) Mouse Monoclonal Primary Antibody, VENTANA anti-PMS2...
DEN170030 · PZJ
Ventana Medical Systems
Pathology · 150d
Cleared Oct 04, 2017
Philips IntelliSite Pathology Solution
K172174 · PSY
Philips Medical Systems Nederland B.V.
Pathology · 77d
Cleared Jul 21, 2017
BOND Ready-to-Use (RTU) Primary Antibody Progesterone Receptor (16),...
K171753 · MXZ
Leica Biosystems Newcastle, Limited
Pathology · 39d
Not Cleared Apr 12, 2017
Philips IntelliSite Pathology Solution
DEN160056 · PSY
Philips Medical Systems Nederland B.V.
Pathology · 132d
Not Cleared Mar 27, 2017
ipsogen JAK2 RGQ PCR Kit
DEN160028 · PSU
Qiagen, Inc.
Pathology · 269d
Not Cleared Mar 04, 2017
CINtec Histology (50 tests), CINtec Histology (250 tests)
DEN160019 · PRB
Ventana Medical Systems, Inc.
Pathology · 285d
Cleared Jan 13, 2017
Kolplast Cervical Sample Collection Kit
K153128 · HHT
Kolplast CI SA
Pathology · 442d
Cleared May 03, 2016
FLEX Monoclonal Rabbitt Anti-Human Estrogen Receptor a, Clone EP1,...
K160922 · MXZ
Dako North America, Inc.
Pathology · 29d
Cleared Jul 16, 2015
Virtuoso System for IHC PR (1E2) using iScan HT
K142965 · OEO
Ventana Medical Systems, Inc.
Pathology · 275d
Cleared Jan 23, 2015
MAMMAPRINT FFPE
K141142 · NYI
Agendia
Pathology · 266d
Cleared Jan 15, 2015
GENASIS HIPATH IHC FAMILY
K140957 · NQN
Applied Spectral Imaging , Ltd.
Pathology · 276d
Not Cleared Dec 15, 2014
PERKINELMER ENLITE NEONATAL TREC TEST SYSTEM
DEN140010 · PJI
Wallac OY
Pathology · 299d
Cleared Nov 07, 2014
PROSIGNA BREAST CANCER PROGNOSTIC GENE SIGNATURE ASSAY
K141771 · NYI
Nanostring Technologies, Inc.
Pathology · 129d
Cleared Jul 29, 2014
APERIO EPATHOLOGY EIHC IVD SYSTEM
K141109 · NOT
Leica Biosystems Imaging, Inc.
Pathology · 91d
Cleared Jun 13, 2014
IMPACT DX FACTOR V LEIDEN AND FACTOR II GENOTYPING TEST
K132978 · PHJ
Sequenom, Inc.
Pathology · 263d
Cleared May 19, 2014
VISION BIOSYSTEMS ESTROGEN RECEPTOR CLONE 6F11 (ER 6F11)
K122556 · MYA
Leica Biosystems Newcastle, Ltd.
Pathology · 635d
Cleared May 09, 2014
DUET SYSTEM
K130775 · NTH
Bioview , Ltd.
Pathology · 415d
Cleared Apr 01, 2014
OMNYX IDP FOR HER2 MANUAL APPLICATION
K131140 · OEO
Omnyx, LLC
Pathology · 344d
Cleared Mar 20, 2014
VIRTUOSO SYSTEM FOR IHC ER (SP1) WITH BENCHMARK ULTRA STAINER
K140465 · NQN
Ventana Medical Systems, Inc.
Pathology · 24d