Product code MKQ ยท Class 3
Processor, Cervical Cytology Slide, Automated
0510(k)s in 12 months (0 all time)
0recalls in 12 months (29 all time)
0recalls that name a 510(k)
Top companies in MKQ
| Company | 510(k)s | Recalls |
|---|---|---|
| Tripath Imaging, Inc. | 0 | 24 |
| Becton Dickinson & Co. | 0 | 4 |
| Bd Diagnostic Systems Tripath | 0 | 1 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 12, 2016 | Becton Dickinson & Co. BD SurePathTM Preservative Collection Vials, catalog numbers 490505, 490527, 491095, 491096, and 491097.
SurePath Preservative Fluid is designed for use with the PrepStain System. SurePath Preservat Terminated |
MKQ | None listed |
| Aug 28, 2013 | Becton Dickinson & Co. PrepStain Tecan US-II.
For use in the screening and detection of cervical cancer. Terminated |
MKQ | None listed |
| Aug 28, 2013 | Becton Dickinson & Co. PrepStain Tecan US-I.
For use in the screening and detection of cervical cancer. Terminated |
MKQ | None listed |
| Aug 28, 2013 | Becton Dickinson & Co. PrepStain AG.
For use in the screening and detection of cervical cancer. Terminated |
MKQ | None listed |
| 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 |
| Mar 19, 2009 | Bd Diagnostic Systems Tripath BD PrepStain System, Model Number: 799-14000-00; Catalog Number: 05CR000021, 05CR00021R, 799-13000-00, 799-13000-00R, 799-14000-00 and 799-14000-00R; Catalog Number: 05CR000021, 05CR000021R, 799-13000 Terminated |
MKQ | None listed |
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