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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Pathology ×
1,105 results
145–168 of 1,105
Search insights Median review: 34d Cleared: 98% Top manufacturer: J R Scientific Lead specialty: Pathology
Cleared May 08, 2009
MONOCLONAL RABBIT ANTI HUMAN ESTROGEN RECEPTOR ALPHA ANTIBODY CLONE SP1,...
K081286 · MYA
Dako North America, Inc.
Pathology · 366d
Cleared Feb 04, 2009
PATHIAM SYSTEM FOR HER2/NEU IMMUNOHISTOCHEMISTRY REAGENTS & KITS
K080910 · NOT
Bioimagene, Inc.
Pathology · 309d
Cleared Feb 04, 2009
MODIFICATION TO PAXGENE BLOOD RNA SYSTEM
K082150 · NTW
Preanalytix GmbH
Pathology · 189d
Cleared Feb 03, 2009
SYSMEX UF-500I AUTOMATED URINE PARTICLE ANALYZER
K083002 · LKM
Sysmex America, Inc.
Pathology · 118d
Cleared Dec 16, 2008
INTROL CF PANEL I CONTROL, MODEL: G106
K083171 · NZB
Maine Molecular Quality Controls, Inc.
Pathology · 50d
Cleared Oct 31, 2008
SCANSCOPE XT SYSTEM
K080254 · OEO
Aperio Technologies
Pathology · 274d
Cleared Oct 17, 2008
ICONOSCOPE ONCOFISH HER2 TEST SYSTEM, MODEL 2000
K080909 · NTH
Ikonisys, Inc.
Pathology · 199d
Cleared Aug 01, 2008
SCANSCOPE XT SYSTEM
K073677 · NQN
Aperio Technologies
Pathology · 217d
Cleared Jul 30, 2008
PATHWORK DIAGNOSTICS TISSUE OF ORIGIN TEST
K080896 · OIW
Pathwork Diagnostics, Inc.
Pathology · 121d
Cleared Jul 21, 2008
MODIFICATION TO MAMMAPRINT
K080252 · NYI
Agendia BV
Pathology · 172d
Cleared May 02, 2008
SYSMEX UF-1000I, AUTOMATED URINE PARTICLE ANALYZER WITH URINALYSIS WAM SOFTWARE
K080887 · LKM
Sysmex America, Inc.
Pathology · 32d
Cleared Mar 13, 2008
INPLEX CF MOLECULAR TEST
K063787 · NUA
Third Wave Technologies, Inc.
Pathology · 448d
Cleared Feb 26, 2008
CELLSEARCH CIRCULATING TUMOR CELL KIT
K073338 · NQI
Veridex, LLC
Pathology · 90d
Cleared Dec 28, 2007
SCANSCOPE XT SYSTEM
K071671 · OEO
Aperio Technologies
Pathology · 192d
Cleared Nov 20, 2007
CELLSEARCH CIRCULATING TUMOR CELL KIT
K071729 · NQI
Veridex, LLC
Pathology · 148d
Cleared Oct 10, 2007
SCANSCOPE XT SYSTEM
K071128 · NOT
Aperio Technologies
Pathology · 170d
Cleared Sep 07, 2007
CYSTIC FIBROSIS GENOTYPING ASSAY, MODEL 6L20-01
K062028 · NUA
Celera Diagnostics
Pathology · 416d
Cleared Jun 22, 2007
MAMMAPRINT
K070675 · NYI
Agendia BV
Pathology · 102d
Cleared May 25, 2007
SYSMEX MODEL UF1000I
K070910 · LKM
Sysmex America, Inc.
Pathology · 53d
Cleared Feb 20, 2007
PATHIAM IMAGING SOFTWARE FOR HER2/NEU
K062756 · NOT
Bioimagene, Inc.
Pathology · 159d
Cleared Feb 07, 2007
INFINITI SYSTEM
K060564 · NPQ
AutoGenomics, Inc.
Pathology · 341d
Not Cleared Feb 06, 2007
MAMMAPRINT
DEN070009 · NYI
Agendia BV
Pathology · 7d
Cleared Jan 29, 2007
VISION BIOSYSTEMS PROGESTERONE RECEPTOR PGR CLONE 16
K062615 · MXZ
Vision Biosystems, Inc.
Pathology · 146d
Cleared Jan 10, 2007
VENTANA IMAGE ANALYSIS SYSTEM - PATHWAY HER2 (4B5)
K061613 · NQN
Tripath Imaging
Pathology · 215d