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
193–216 of 1,099
Search insights Median review: 34d Cleared: 98% Top manufacturer: J R Scientific Lead specialty: Pathology
Cleared Dec 18, 2003
FACTOR II (PROTHROMBIN) G20210A KIT
K033612 · NPR
Roche Diagnostics Corp.
Pathology · 31d
Not Cleared Dec 17, 2003
FACTOR V LEIDEN KIT
DEN030005 · NPQ
Roche Diagnostics Corp.
Pathology · 9d
Cleared Jun 18, 2003
QCS HER2 IMMUNOCONTROLS (PRODUCT NO. C010)
K023335 · NJW
Qc Sciences, LLC
Pathology · 254d
Cleared Dec 02, 2002
SST SALIVA SUPPORTING TABLETS
K023046 · LED
Sinclair Pharmaceuticals, Ltd.
Pathology · 81d
Cleared Oct 21, 2002
IQ 200 SYSTEM
K022774 · LKM
Intl. Remote Imaging Systems
Pathology · 61d
Cleared Sep 30, 2002
MODIFICATION TO ACIS (AUTOMATED CELLULAR IMAGING SYSTEM)
K012138 · MYA
Chroma Vision Medical Systems, Inc.
Pathology · 447d
Cleared Mar 08, 2002
BIOGENEX MONOCLONAL ANTI-PROGESTERONE RECEPTOR
K012960 · MXZ
Biogenex Laboratories
Pathology · 185d
Cleared Feb 28, 2002
BIOGENEX MONOCLONAL ANTI-ESTROGEN RECEPTOR(CLONE ER88)
K013148 · MYA
Biogenex Laboratories
Pathology · 161d
Cleared Feb 28, 2002
DAKO MONOCLONAL MOUSE ANTI-HUMAN PROGESTERONE RECEPTOR, CLONE PGR 636,...
K020023 · MXZ
Dako Corp.
Pathology · 56d
Cleared Sep 28, 2001
SYSMEX UF-50
K012372 · LKM
Sysmex Corp.
Pathology · 64d
Cleared Sep 14, 2001
BANDVIEW SYSTEM
K012103 · LNJ
Applied Spectral Imaging , Ltd.
Pathology · 71d
Cleared Apr 13, 2001
ANEUVYSION MULITICOLOR DNA PROBE KIT
K010288 · OYU
Vysis
Pathology · 72d
Cleared May 18, 2000
PRO.DUCT HEALTH MICRO-STYLET, MODEL STY01
K001098 · FMI
Pro. Duct Health, Inc.
Pathology · 44d
Cleared Apr 14, 2000
939UDX URINE PATHOLOGY SYSTEM
K000373 · LKM
Intl. Remote Imaging Systems
Pathology · 70d
Cleared Mar 03, 2000
DAKO MONOCLONAL MOUSE ANTI-HUMAN ESTROGEN RECEPTOR
K993957 · MYA
Dako Corp.
Pathology · 102d
Cleared Feb 23, 2000
IMMUNOCYT
K994356 · NBK
Diagnocure, Inc.
Pathology · 62d
Cleared Aug 12, 1999
VENTANA ER PRIMARY ANTIBODY (CLONE 6F11)
K984567 · MYA
Ventana, Inc.
Pathology · 232d
Cleared Jul 23, 1999
VENTANA PGR PRIMARY ANTIBODY (CLONE 1A6)
K990618 · MXZ
Ventana Medical Systems, Inc.
Pathology · 148d
Cleared Oct 24, 1997
CRAFT DUO-VAC SUCTION UNIT, CRAFT SUCTION UNIT
K972867 · ICX
Rocket Medical Plc
Pathology · 81d
Cleared Oct 20, 1997
ANEUVYSION
K972200 · OYU
Vysis
Pathology · 132d
Cleared Jul 22, 1997
VACUTAINER BRAND SAFETY BLOOD COLLECTION ASSEMBLY(MULTIPLE)
K972404 · KJA
Bd Becton Dickinson Vacutainer...
Pathology · 26d
Cleared Jan 21, 1997
CEP X SPECTRUMORANGE\Y SPECTRUMGREEN DNA PROBE KIT
K954214 · OXP
Vysis
Pathology · 502d
Cleared Jan 13, 1997
CEP 12 SPECTRUMORANGE DIRECT LABELED CHROMOSOME ENUMERATION DNA PROBE
K962873 · OVQ
Vysis
Pathology · 174d
Cleared Nov 29, 1996
CEP 8 SPECTRUMORANGE DNA PROBE KIT
K953591 · OYU
Vysis
Pathology · 486d