FDA Product Code
FDA Product Code NTH — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Immunology
- 21 CFR Citation
- 866.4700
510(k) Clearances — 8 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K130775 | DUET SYSTEM | Bioview , Ltd. | 2014-05-09 | Traditional | PDF ↗ |
| K122554 | GENASIS SCANVIEW SYSTEM | Applied Spectral Imaging , Ltd. | 2013-02-07 | Traditional | PDF ↗ |
| K110345 | SCANVIEW SYSTEM | Applied Spectral Imaging | 2011-10-19 | Traditional | PDF ↗ |
| K101291 | SCANVIEW HER2/NEU FISH SYSTEM | Applied Spectral Imaging , Ltd. | 2010-11-23 | Traditional | PDF ↗ |
| K080909 | ICONOSCOPE ONCOFISH HER2 TEST SYSTEM, MODEL 2000 | Ikonisys, Inc. | 2008-10-17 | Traditional | PDF ↗ |
| K043519 | ARIOL HER-2/NEU FISH | Applied Imaging Corp. | 2005-04-25 | Traditional | PDF ↗ |
| K042542 | CYTOVISION FOR CEP XY | Applied Imaging Corp. | 2005-01-10 | Traditional | PDF ↗ |
| DEN040010 | VYSIS AUTOVYSION SYSTEM | Vysis | 2004-12-13 | Post-NSE | — |
Product code NTH · Class II · Immunology. Data: openFDA.