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Tripath Imaging, Inc.

FDA Regulatory Profile

Summary

Total Recalls
9
510(k) Clearances
5
Inspections
0
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-1814-2012Class IIIManual Method 1: 480 Test Kit (PreCoat), Catalog/Model # 490529March 22, 2012
Z-1812-2012Class IIIPrepStain GYN 480 Disposable Test Kit with PreCoat Slides (Catalog #490523March 22, 2012
Z-1813-2012Class IIIPrepStain Installation Kit (PreCoat), Catalog/Model # 490528March 22, 2012
Z-1815-2012Class IIIPrepStain GN 480 Disposable Kit Catalog/Model 490542 This is a complete kit, per the firm's explanaMarch 22, 2012
Z-1811-2012Class IIIPrepStain Syringing Pipettes 240 (Catalog #490517)March 22, 2012
Z-2086-2012Class IIPrepStain Upgrade Kit: 1.3.0.3/1.2 DiTi Cone. The PrepStain System is a liquid-based thin layer cDecember 8, 2011
Z-2085-2012Class IIPrepStain Kit: 1.2 DiTi Cone. The PrepStain System is a liquid-based thin layer cell preparation December 8, 2011
Z-2087-2012Class IIPrepStain Slide Processor. The PrepStain System is a liquid-based thin layer cell preparation proDecember 8, 2011
Z-2088-2012Class IIPrepStain PM Kit, T-AG (Catalog 490588); PrepStain PM Kit Europe (Catalog 490671); PrepStain Prep OnDecember 8, 2011

Recent 510(k) Clearances

K-NumberDeviceDate
K061613VENTANA IMAGE ANALYSIS SYSTEM - PATHWAY HER2 (4B5)January 10, 2007
K062428VENTANA IMAGE ANALYSIS SYSTEM, MODEL VIASSeptember 29, 2006
K053520VENTANA IMAGE ANALYSIS SYSTEM, MODEL KI-67April 11, 2006
K051282VENTANA IMAGE ANALYSIS SYSTEM - HER2/NEUAugust 16, 2005
K050012VENTANA IMAGE ANALYSIS SYSTEMMay 6, 2005