NTH — System, Automated Scanning Microscope And Image Analysis For Fluorescence In Situ Hybridization (Fish) Assays Class II
FDA product code NTH covers "System, Automated Scanning Microscope And Image Analysis For Fluorescence In Situ Hybridization (Fish) Assays", a Class II medical device regulated under 21 CFR 866.4700. Submissions are reviewed by the Immunology panel. At least 8 recent 510(k) clearances have been granted under this product code.
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 |