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
97–120 of 1,099
Search insights Median review: 34d Cleared: 98% Top manufacturer: J R Scientific Lead specialty: Pathology
Cleared Sep 06, 2013
VIRTUOSO SYSTEM FOR IHC KI-67 (30-9)
K121033 · NOT
Ventana Medical Systems, Inc.
Pathology · 519d
Cleared Sep 06, 2013
PROSIGNA(TM) BREAST CANCER PROGNOSTIC GENE SIGNATURE ASSAY
K130010 · NYI
Nanostring Technologies
Pathology · 246d
Not Cleared Jul 29, 2013
VYSIS EGR1 FISH PROBE KIT - SC (SPECIMEN CHARACTERIZATION)
DEN130010 · PDO
Abbott Molecular, Inc.
Pathology · 111d
Cleared Jun 20, 2013
CELLTRACKS ANALYZER II SYSTEM
K130794 · NQI
Veridex, LLC
Pathology · 90d
Cleared Feb 12, 2013
MONOCLONAL RABBIT ANTI-HUMAN ESTROGEN RECEPTOR (ER) A, CLONE EPI
K120663 · MYA
Dako North America, Inc.
Pathology · 344d
Cleared Feb 07, 2013
GENASIS SCANVIEW SYSTEM
K122554 · NTH
Applied Spectral Imaging , Ltd.
Pathology · 170d
Cleared Dec 17, 2012
CONFIRM ANTI-ESTROGEN RECEPTOR (SP1) RABBIT MONOCLONAL PRIMARY ANTIBODY
K110215 · MYA
Ventana Medical Systems, Inc.
Pathology · 719d
Cleared Dec 13, 2012
CELLTRACKS AUTOPREP SYSTEM
K122821 · NQI
Veridex, LLC
Pathology · 90d
Cleared Aug 21, 2012
VIRTUAL SLIDE SYSTEM, OLYMPUS VS800 SYSTEM
K111914 · OEO
Olympus America Inc. / Scientific...
Pathology · 412d
Cleared Jun 01, 2012
VIRTUSO SYSTEM FOR IHC (DO-7)
K121350 · NOT
Ventana Medical Systems, Inc.
Pathology · 28d
Cleared May 17, 2012
TISSUE OF ORIGIN TEST KIT FFPE
K120489 · OIW
Pathwork Diagnostics, Inc.
Pathology · 90d
Cleared Apr 19, 2012
VIRTUOSO SYSTEM FOR IHC P53 (DO-7)
K111872 · NQN
Ventana Medical Systems, Inc.
Pathology · 293d
Cleared Mar 16, 2012
RNARETAIN
K113420 · OZF
Asuragen, Inc.
Pathology · 119d
Cleared Mar 05, 2012
VIRTUOSO SYSTEM FOR IHC PR (IE2)
K111869 · NQN
Ventana Medical Systems, Inc.
Pathology · 248d
Cleared Feb 22, 2012
VIRTUOSO SYSTEM FOR IHC KI-67 (30-9)
K111755 · NOT
Ventana Medical Systems, Inc.
Pathology · 245d
Cleared Jan 20, 2012
CELLTRACKS AUTOPREP SYSTEM
K110406 · NQI
Veridex, LLC
Pathology · 340d
Cleared Dec 12, 2011
CELLTRACKS ANALYER II
K113181 · NQI
Veridex, LLC
Pathology · 45d
Cleared Nov 16, 2011
CONFIRM ANTI-PROGESTORONE RECEPTOR (1E2) RABBIT MONOCLONAL PRIMARY ANTIBODY
K103818 · MXZ
Ventana Medical Sytems, Inc.
Pathology · 322d
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