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
121–144 of 1,105
Search insights Median review: 34d Cleared: 98% Top manufacturer: J R Scientific Lead specialty: Pathology
Cleared Oct 19, 2011
SCANVIEW SYSTEM
K110345 · NTH
Applied Spectral Imaging
Pathology · 257d
Cleared Oct 12, 2011
VIRTUOSO (TM) SYSTEM FOR IHC HER2 (4B5)
K111543 · NOT
Ventana Medical Systems, Inc.
Pathology · 132d
Cleared Aug 29, 2011
VYSIS EGR1 FISH PROBE KIT (VYSIS LSI EGR1 SPECTRUM/ORANGE/D5S23, D5S721,...
K091960 · OWK
Abbott Molecular, Inc.
Pathology · 789d
Cleared Aug 09, 2011
VYSIS CLL FISH PROBE KIT (VYSIS LSI TP53 SPECTRUMORANGE/ATM SPECTRUMGREEN)...
K100015 · OVQ
Abbott Molecular, Inc.
Pathology · 582d
Cleared Jun 02, 2011
INVADER FACTOR II
K100943 · NPR
Hologic, Inc.
Pathology · 422d
Cleared Jun 01, 2011
INVADER FACTOR V
K100980 · NPQ
Hologic, Inc.
Pathology · 419d
Cleared May 13, 2011
INVADER MTHFR 677
K100987 · OMM
Hologic, Inc.
Pathology · 399d
Cleared Apr 25, 2011
INVADER MTHFR 1298
K100496 · OMM
Hologic, Inc.
Pathology · 427d
Cleared Jan 28, 2011
MAMMAPRINT
K101454 · NYI
Agendia
Pathology · 248d
Cleared Dec 21, 2010
CELLSEARCH CIRCULATING TUMOR CELL KIT MODEL 7900001
K103502 · NQI
Veridex, LLC
Pathology · 22d
Cleared Nov 23, 2010
SCANVIEW HER2/NEU FISH SYSTEM
K101291 · NTH
Applied Spectral Imaging , Ltd.
Pathology · 200d
Cleared Oct 27, 2010
PATHIAM SYSTEM WITH ISCAN FOR P53 AND KI-67
K092333 · NQN
Bioimagene, Inc.
Pathology · 449d
Cleared Jun 08, 2010
PATHWORK TISSUE OF ORIGIN TEST KIT-FFPE (ORIGIN TEST KIT-FFPE
K092967 · OIW
Pathwork Diagnostics
Pathology · 256d
Cleared May 04, 2010
HEMOSIL F11 & FV DNA CONTROL
K093737 · NZB
Instrumentation Laboratory CO
Pathology · 151d
Cleared Apr 28, 2010
ILLUMINA VERNCODE GENOTYPING TEST FOR FACOR V AND FACTOR II
K093129 · NPQ
Illumina, Inc.
Pathology · 208d
Cleared Apr 22, 2010
ESENOR FII-FV-MTHFR GENOTYPING TEST, ESENOR FII-FV GENOTYPING TEST, ESENOR...
K093974 · NPQ
Osmetech Molecular Diagnostics
Pathology · 120d
Cleared Feb 05, 2010
IQ 20 SERIES ANALYZER, IQ 200 SERIES SYSTEM, NAD IQ LAMINA CRADLE
K093861 · LKM
Iris International, Inc.
Pathology · 51d
Cleared Dec 11, 2009
MODIFICATION TO MAMMAPRINT
K081092 · NYI
Agendia
Pathology · 603d
Cleared Dec 11, 2009
XTAG CF60 KIT V2
K083845 · NUA
Luminex Molecular Diagnostics, Inc.
Pathology · 352d
Cleared Sep 18, 2009
XPERT HEMOSIL FACTOR II & FACTOR V ASSAY
K082118 · NPQ
Cepheid
Pathology · 417d
Cleared Sep 01, 2009
XTAG CYSTIC FIBROSIS 39 KIT V2, (CFTR 39 KIT V2), MODEL I027C0231, I027D0266,...
K083846 · NUA
Luminex Molecular Diagnostics, Inc.
Pathology · 251d
Cleared Aug 14, 2009
SCANSCOPE XT SYSTEM
K080564 · NOT
Aperio Technologies
Pathology · 533d
Cleared Jul 24, 2009
VERIGENE CFTR NUCLEIC ACID TEST AND VERIGENE CFTR POLYT NUCLEIC ACID TEST
K083294 · NUA
Nanosphere, Inc.
Pathology · 256d
Cleared Jul 06, 2009
ESENSOR CF GENOTYPING TESTM ESENSOR SYSTEM, ESENSOR CYSTIC FIBROSIS...
K090901 · NUA
Osmetech Molecular Diagnostics
Pathology · 96d