Panels › Immunology › Product code NTH · Class 2
System, Automated Scanning Microscope And Image Analysis For Fluorescence In Situ Hybridization (Fish) Assays
Regulation 866.4700
0510(k)s in 12 months (8 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in NTH
| Company | 510(k)s | Recalls |
|---|---|---|
| Applied Spectral Imaging | 3 | 0 |
| Applied Imaging Corp. | 2 | 0 |
| Bioview , Ltd. | 1 | 0 |
| Ikonisys, Inc. | 1 | 0 |
| Vysis | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| May 9, 2014 | K130775 | DUET SYSTEM Bioview , Ltd., IL | NTH |
| Feb 7, 2013 | K122554 | GENASIS SCANVIEW SYSTEM Applied Spectral Imaging , Ltd., IL | NTH |
| Oct 19, 2011 | K110345 | SCANVIEW SYSTEM Applied Spectral Imaging, IL | NTH |
| Nov 23, 2010 | K101291 | SCANVIEW HER2/NEU FISH SYSTEM Applied Spectral Imaging , Ltd., IL | NTH |
| Oct 17, 2008 | K080909 | ICONOSCOPE ONCOFISH HER2 TEST SYSTEM, MODEL 2000 Ikonisys, Inc. | NTH |
| Apr 25, 2005 | K043519 | ARIOL HER-2/NEU FISH Applied Imaging Corp. | NTH |
| Jan 10, 2005 | K042542 | CYTOVISION FOR CEP XY Applied Imaging Corp. | NTH |
| Dec 13, 2004 | DEN040010 | VYSIS AUTOVYSION SYSTEM Vysis | NTH |
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