Tripath Imaging, Inc.
FDA Regulatory Profile
Tripath Imaging, Inc. appears in FDA public data with 9 recalls, 5 510(k) clearances, 0 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-1814-2012, Class III) was initiated on March 22, 2012. Its most recent 510(k) clearance was granted on January 10, 2007.
Summary
- Total Recalls
- 9
- 510(k) Clearances
- 5
- Inspections
- 0
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-1814-2012 | Class III | Manual Method 1: 480 Test Kit (PreCoat), Catalog/Model # 490529 | March 22, 2012 |
| Z-1812-2012 | Class III | PrepStain GYN 480 Disposable Test Kit with PreCoat Slides (Catalog #490523 | March 22, 2012 |
| Z-1813-2012 | Class III | PrepStain Installation Kit (PreCoat), Catalog/Model # 490528 | March 22, 2012 |
| Z-1815-2012 | Class III | PrepStain GN 480 Disposable Kit Catalog/Model 490542 This is a complete kit, per the firm's explana | March 22, 2012 |
| Z-1811-2012 | Class III | PrepStain Syringing Pipettes 240 (Catalog #490517) | March 22, 2012 |
| Z-2087-2012 | Class II | PrepStain Slide Processor. The PrepStain System is a liquid-based thin layer cell preparation pro | December 8, 2011 |
| Z-2088-2012 | Class II | PrepStain PM Kit, T-AG (Catalog 490588); PrepStain PM Kit Europe (Catalog 490671); PrepStain Prep On | December 8, 2011 |
| Z-2086-2012 | Class II | PrepStain Upgrade Kit: 1.3.0.3/1.2 DiTi Cone. The PrepStain System is a liquid-based thin layer c | December 8, 2011 |
| Z-2085-2012 | Class II | PrepStain Kit: 1.2 DiTi Cone. The PrepStain System is a liquid-based thin layer cell preparation | December 8, 2011 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K061613 | VENTANA IMAGE ANALYSIS SYSTEM - PATHWAY HER2 (4B5) | January 10, 2007 |
| K062428 | VENTANA IMAGE ANALYSIS SYSTEM, MODEL VIAS | September 29, 2006 |
| K053520 | VENTANA IMAGE ANALYSIS SYSTEM, MODEL KI-67 | April 11, 2006 |
| K051282 | VENTANA IMAGE ANALYSIS SYSTEM - HER2/NEU | August 16, 2005 |
| K050012 | VENTANA IMAGE ANALYSIS SYSTEM | May 6, 2005 |