FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ 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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Pathology ×
1,109 results
193–216 of 1,109
Search insights Median review: 34d Cleared: 98% Top manufacturer: J R Scientific Lead specialty: Pathology
Cleared Mar 15, 2005
CELLTRACKA ANALYZER II
K050145 · NQI
Immunicon Corp.
Pathology · 50d
Cleared Mar 15, 2005
CELLSEARCH CIRCULATING TUMOR CELL KIT
K050245 · NQI
Veridex, LLC
Pathology · 41d
Cleared Feb 15, 2005
DAKOCYTOMATION ER/PR PHARMDX KIT
K042884 · MXZ
Dakocytomation California, Inc.
Pathology · 119d
Cleared Feb 09, 2005
PROSTATE-63 CANCER DIAGNOSTIC TEST
K050063 · NTR
Asymmetrx
Pathology · 29d
Not Cleared Dec 13, 2004
VYSIS AUTOVYSION SYSTEM
DEN040010 · NTH
Vysis
Pathology · 61d
Cleared Mar 18, 2004
ARIOL
K033200 · NQN
Applied Imaging Corp.
Pathology · 168d
Cleared Feb 05, 2004
QCA (VERSION 3.1)
K031363 · NQN
Cell Analysis, Inc.
Pathology · 281d
Not Cleared Jan 21, 2004
CELLSEARCH EPITHELIAL CELL ENRICHMENT KIT
DEN040001 · NQI
Advanced Diagnostic Systems
Pathology · 19d
Cleared Jan 08, 2004
ARIOL HER-2/NEU IHC
K031715 · NOT
Applied Imaging Corp.
Pathology · 220d
Cleared Dec 23, 2003
ACIS (AUTOMATED CELLULAR IMAGING SYSTEM)
K032113 · NOT
Chroma Vision Medical Systems, Inc.
Pathology · 167d
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