Company ยท US
Tripath Imaging, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 2005 to 2007. Name variants (Inc, Corp, punctuation) are merged.
5510(k) clearances (0 in 12 months)
24recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jan 10, 2007 | K061613 | VENTANA IMAGE ANALYSIS SYSTEM - PATHWAY HER2 (4B5) Tripath Imaging | NQN |
| Sep 29, 2006 | K062428 | VENTANA IMAGE ANALYSIS SYSTEM, MODEL VIAS Tripath Imaging, Inc. | NQN |
| Apr 11, 2006 | K053520 | VENTANA IMAGE ANALYSIS SYSTEM, MODEL KI-67 Tripath Imaging, Inc. | NQN |
| Aug 16, 2005 | K051282 | VENTANA IMAGE ANALYSIS SYSTEM - HER2/NEU Tripath Imaging, Inc. | NOT |
| May 6, 2005 | K050012 | VENTANA IMAGE ANALYSIS SYSTEM Tripath Imaging, Inc. | NQN |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 26, 2012 | Tripath Imaging, Inc. PrepStain PM Kit, T-AG (Catalog 490588); PrepStain PM Kit Europe (Catalog 490671); PrepStain Prep Only PM Kit, T-AG (Catalog 490954); PrepStain PM Kit XLP, T-US-II (Catalog 490424); PrepStain Prep PM Terminated |
MKQ | None listed |
| Jul 26, 2012 | Tripath Imaging, Inc. PrepStain Slide Processor.
The PrepStain System is a liquid-based thin layer cell preparation process. The PrepStain System produces SurePath Slides that are intended for use in the screening and det Terminated |
MKQ | None listed |
| Jul 26, 2012 | Tripath Imaging, Inc. PrepStain Upgrade Kit: 1.3.0.3/1.2 DiTi Cone.
The PrepStain System is a liquid-based thin layer cell preparation process. The PrepStain System produces SurePath Slides that are intended for use in th Terminated |
MKQ | None listed |
| Jul 26, 2012 | Tripath Imaging, Inc. PrepStain Kit: 1.2 DiTi Cone.
The PrepStain System is a liquid-based thin layer cell preparation process. The PrepStain System produces SurePath Slides that are intended for use in the screening and Terminated |
MKQ | None listed |
| Jun 15, 2012 | Tripath Imaging, Inc. PrepStain GN 480 Disposable Kit Catalog/Model 490542
This is a complete kit, per the firm's explanation, that contains the PrepStain Syringing Pipettes 240, the product being recalled. The affected lo Terminated |
MKQ | None listed |
| Jun 15, 2012 | Tripath Imaging, Inc. Manual Method 1: 480 Test Kit (PreCoat), Catalog/Model # 490529 Terminated |
MKQ | None listed |
| Jun 15, 2012 | Tripath Imaging, Inc. PrepStain Installation Kit (PreCoat), Catalog/Model # 490528 Terminated |
MKQ | None listed |
| Jun 15, 2012 | Tripath Imaging, Inc. PrepStain GYN 480 Disposable Test Kit with PreCoat Slides (Catalog #490523 Terminated |
MKQ | None listed |
| Jun 15, 2012 | Tripath Imaging, Inc. PrepStain Syringing Pipettes 240 (Catalog #490517) Terminated |
MKQ | None listed |
| May 21, 2012 | Tripath Imaging, Inc. BD Focal Point"230V LC (Refurbished), Catalog number: 490681.
The BD Focal Point" Slide Profiler (formerly the AutoPap System) is an automated cervical cytology screening device intended for use in Terminated |
MKQ | None listed |
| May 21, 2012 | Tripath Imaging, Inc. BD Focal Point"230V / 15 FOV (Refurbished), Catalog number: 490138.
The BD Focal Point" Slide Profiler (formerly the AutoPap System) is an automated cervical cytology screening device intended for u Terminated |
MKQ | None listed |
| May 21, 2012 | Tripath Imaging, Inc. BD Focal Point"230V / 15 FOV under 5%, Catalog number: 490137.
The BD Focal Point" Slide Profiler (formerly the AutoPap System) is an automated cervical cytology screening device intended for use in Terminated |
MKQ | None listed |
| May 21, 2012 | Tripath Imaging, Inc. BD Focal Point"230V / 11 FOV (Refurbished), Catalog number: 490649.
The BD Focal Point" Slide Profiler (formerly the AutoPap System) is an automated cervical cytology screening device intended for u Terminated |
MKQ | None listed |
| May 21, 2012 | Tripath Imaging, Inc. BD Focal Point"230V / 11 FOV under 5%, Catalog number: 490648.
The BD Focal Point" Slide Profiler (formerly the AutoPap System) is an automated cervical cytology screening device intended for use in Terminated |
MKQ | None listed |
| May 21, 2012 | Tripath Imaging, Inc. BD Focal Point"120V LC (Refurbished), Catalog number: 490683.
The BD Focal Point" Slide Profiler (formerly the AutoPap System) is an automated cervical cytology screening device intended for use in Terminated |
MKQ | None listed |
| May 21, 2012 | Tripath Imaging, Inc. BD Focal Point"120V / 15 FOV (Refurbished), Catalog number: 490398.
The BD Focal Point" Slide Profiler (formerly the AutoPap System) is an automated cervical cytology screening device intended for u Terminated |
MKQ | None listed |
| May 21, 2012 | Tripath Imaging, Inc. BD Focal Point"120v / 15 FOV under 5%, Catalog number: 490397.
The BD Focal Point" Slide Profiler (formerly the AutoPap System) is an automated cervical cytology screening device intended for use in Terminated |
MKQ | None listed |
| May 21, 2012 | Tripath Imaging, Inc. BD Focal Point"120V / 11 FOV (Refurbished), Catalog number: 490653.
The BD Focal Point" Slide Profiler (formerly the AutoPap System) is an automated cervical cytology screening device intended for u Terminated |
MKQ | None listed |
| May 21, 2012 | Tripath Imaging, Inc. BD Focal Point"120V / 11 FOV under 5%, Catalog number: 490652
The BD Focal Point" Slide Profiler (formerly the AutoPap System) is an automated cervical cytology screening device intended for use in Terminated |
MKQ | None listed |
| May 21, 2012 | Tripath Imaging, Inc. BD Focal Point"100V LC (Refurbished), Catalog number: 490682
The BD Focal Point" Slide Profiler (formerly the AutoPap System) is an automated cervical cytology screening device intended for use in i Terminated |
MKQ | None listed |
| May 21, 2012 | Tripath Imaging, Inc. BD Focal Point"100V / 15 FOV under 5%, Catalog number: (Refurbished) 490365
The BD Focal Point" Slide Profiler (formerly the AutoPap System) is an automated cervical cytology screening device intende Terminated |
MKQ | None listed |
| May 21, 2012 | Tripath Imaging, Inc. BD Focal Point"100V / 15 FOV under 5%, Catalog number: 490364
The BD Focal Point" Slide Profiler (formerly the AutoPap System) is an automated cervical cytology screening device intended for use in Terminated |
MKQ | None listed |
| May 21, 2012 | Tripath Imaging, Inc. BD Focal Point"100V (Refurbished), Catalog number: 490651
The BD Focal Point" Slide Profiler (formerly the AutoPap System) is an automated cervical cytology screening device intended for use in init Terminated |
MKQ | None listed |
| May 21, 2012 | Tripath Imaging, Inc. BD Focal Point"100V, Catalog number: 490650
The BD Focal Point" Slide Profiler (formerly the AutoPap System) is an automated cervical cytology screening device intended for use in initial screening o Terminated |
MKQ | None listed |