FDA 510(k) Regulatory Intelligence Search

Search devices, predicates, manufacturers and submission history used by regulatory affairs and medical device strategy teams.

174,883 clearances · 1976 to present · Updated monthly from FDA records

Filters: Pathology ×
1,099 results
73–96 of 1,099
Search insights Median review: 34d Cleared: 98% Top manufacturer: J R Scientific Lead specialty: Pathology
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
Not Cleared Jan 17, 2014
CYTOSCAN(R) DX
DEN130018 · PFX
Affymetrix, Inc.
Pathology · 30d
Cleared Jan 10, 2014
FLEXMAP 3D
K133302 · NSU
Luminex Corp.
Pathology · 77d
Cleared Dec 09, 2013
MONOCLONAL MOUSE ANTI-HUMAN PROGESTERONE RECEPTOR, CLONE PGR 636,...
K130861 · MXZ
Dako North America, Inc.
Pathology · 256d
Cleared Nov 22, 2013
VIRTUOSO SYSTEM FOR IHC ER (SPI)
K130515 · NQN
Ventana Medical Systems, Inc.
Pathology · 268d
Cleared Nov 19, 2013
ILLUMINA MISEQDX CYSTIC FIBROSIS 139-VARIANT ASSAY
K124006 · PFR
Illumina, Inc.
Pathology · 328d
Cleared Nov 19, 2013
ILLUMINA MISEQDX CYSTIC FIBROSIS CLINICAL SEQUENCING ASSAY
K132750 · PFS
Illumina, Inc.
Pathology · 77d
Cleared Sep 26, 2013
VIRTUOSO SYSTEM FOR IHC HER2 (4B5)
K121516 · NQN
Ventana Medical Systems, Inc.
Pathology · 492d
Cleared Sep 19, 2013
VIRTUOSO SYSTEM FOR IHC PR (1E2) BENCHMARK ULTRA STAINER
K122143 · NQN
Ventana Medical Systems, Inc.
Pathology · 427d
Cleared Sep 19, 2013
PHILIPS HERCEPTEST DIGITAL SCORE
K130021 · OEO
Philips Medical Systems Nederland B.V.
Pathology · 259d
Cleared Sep 13, 2013
VYSIS D7S486/CEP 7 FISH PROBE KIT
K131508 · PFG
Abbott Molecular, Inc.
Pathology · 112d