NTH — System, Automated Scanning Microscope And Image Analysis For Fluorescence In Situ Hybridization (Fish) Assays Class II
FDA Device Classification
Classification Details
- Product Code
- NTH
- Device Class
- Class II
- Regulation Number
- 866.4700
- Submission Type
- Review Panel
- PA
- Medical Specialty
- Immunology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|
| K130775 | bioview | DUET SYSTEM | May 9, 2014 |
| K122554 | applied spectral imaging | GENASIS SCANVIEW SYSTEM | February 7, 2013 |
| K110345 | applied spectral imaging | SCANVIEW SYSTEM | October 19, 2011 |
| K101291 | applied spectral imaging | SCANVIEW HER2/NEU FISH SYSTEM | November 23, 2010 |
| K080909 | ikonisys | ICONOSCOPE ONCOFISH HER2 TEST SYSTEM, MODEL 2000 | October 17, 2008 |
| K043519 | applied imaging | ARIOL HER-2/NEU FISH | April 25, 2005 |
| K042542 | applied imaging | CYTOVISION FOR CEP XY | January 10, 2005 |
| DEN040010 | vysis | VYSIS AUTOVYSION SYSTEM | December 13, 2004 |