FDA Product Code
FDA Product Code NOT — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Hematology
- 21 CFR Citation
- 864.1860
510(k) Clearances — 13 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K260755 | OptraSCAN System | Optrascan, Inc. | 2026-07-02 | Traditional | PDF ↗ |
| K141109 | APERIO EPATHOLOGY EIHC IVD SYSTEM | Leica Biosystems Imaging, Inc. | 2014-07-29 | Traditional | PDF ↗ |
| K121033 | VIRTUOSO SYSTEM FOR IHC KI-67 (30-9) | Ventana Medical Systems, Inc. | 2013-09-06 | Traditional | PDF ↗ |
| K121350 | VIRTUSO SYSTEM FOR IHC (DO-7) | Ventana Medical Systems, Inc. | 2012-06-01 | Traditional | PDF ↗ |
| K111755 | VIRTUOSO SYSTEM FOR IHC KI-67 (30-9) | Ventana Medical Systems, Inc. | 2012-02-22 | Traditional | PDF ↗ |
| K111543 | VIRTUOSO (TM) SYSTEM FOR IHC HER2 (4B5) | Ventana Medical Systems, Inc. | 2011-10-12 | Traditional | PDF ↗ |
| K080564 | SCANSCOPE XT SYSTEM | Aperio Technologies | 2009-08-14 | Traditional | PDF ↗ |
| K080910 | PATHIAM SYSTEM FOR HER2/NEU IMMUNOHISTOCHEMISTRY REAGENTS & KITS | Bioimagene, Inc. | 2009-02-04 | Traditional | PDF ↗ |
| K071128 | SCANSCOPE XT SYSTEM | Aperio Technologies | 2007-10-10 | Traditional | PDF ↗ |
| K062756 | PATHIAM IMAGING SOFTWARE FOR HER2/NEU | Bioimagene, Inc. | 2007-02-20 | Traditional | PDF ↗ |
| K051282 | VENTANA IMAGE ANALYSIS SYSTEM - HER2/NEU | Tripath Imaging, Inc. | 2005-08-16 | Traditional | PDF ↗ |
| K031715 | ARIOL HER-2/NEU IHC | Applied Imaging Corp. | 2004-01-08 | Traditional | PDF ↗ |
| K032113 | ACIS (AUTOMATED CELLULAR IMAGING SYSTEM) | Chroma Vision Medical Systems, Inc. | 2003-12-23 | Traditional | PDF ↗ |
Product code NOT · Class II · Hematology. Data: openFDA.