FDA Product Code
FDA Product Code NQN — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Hematology
- 21 CFR Citation
- 864.1860
510(k) Clearances — 15 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K140957 | GENASIS HIPATH IHC FAMILY | Applied Spectral Imaging , Ltd. | 2015-01-15 | Traditional | PDF ↗ |
| K140465 | VIRTUOSO SYSTEM FOR IHC ER (SP1) WITH BENCHMARK ULTRA STAINER | Ventana Medical Systems, Inc. | 2014-03-20 | Traditional | PDF ↗ |
| K130515 | VIRTUOSO SYSTEM FOR IHC ER (SPI) | Ventana Medical Systems, Inc. | 2013-11-22 | Traditional | PDF ↗ |
| K121516 | VIRTUOSO SYSTEM FOR IHC HER2 (4B5) | Ventana Medical Systems, Inc. | 2013-09-26 | Traditional | PDF ↗ |
| K122143 | VIRTUOSO SYSTEM FOR IHC PR (1E2) BENCHMARK ULTRA STAINER | Ventana Medical Systems, Inc. | 2013-09-19 | Traditional | PDF ↗ |
| K111872 | VIRTUOSO SYSTEM FOR IHC P53 (DO-7) | Ventana Medical Systems, Inc. | 2012-04-19 | Traditional | PDF ↗ |
| K111869 | VIRTUOSO SYSTEM FOR IHC PR (IE2) | Ventana Medical Systems, Inc. | 2012-03-05 | Traditional | PDF ↗ |
| K092333 | PATHIAM SYSTEM WITH ISCAN FOR P53 AND KI-67 | Bioimagene, Inc. | 2010-10-27 | Traditional | PDF ↗ |
| K073677 | SCANSCOPE XT SYSTEM | Aperio Technologies | 2008-08-01 | Traditional | PDF ↗ |
| K061613 | VENTANA IMAGE ANALYSIS SYSTEM - PATHWAY HER2 (4B5) | Tripath Imaging | 2007-01-10 | Traditional | PDF ↗ |
| K062428 | VENTANA IMAGE ANALYSIS SYSTEM, MODEL VIAS | Tripath Imaging, Inc. | 2006-09-29 | Traditional | PDF ↗ |
| K053520 | VENTANA IMAGE ANALYSIS SYSTEM, MODEL KI-67 | Tripath Imaging, Inc. | 2006-04-11 | Traditional | PDF ↗ |
| K050012 | VENTANA IMAGE ANALYSIS SYSTEM | Tripath Imaging, Inc. | 2005-05-06 | Traditional | PDF ↗ |
| K033200 | ARIOL | Applied Imaging Corp. | 2004-03-18 | Traditional | PDF ↗ |
| K031363 | QCA (VERSION 3.1) | Cell Analysis, Inc. | 2004-02-05 | Abbreviated | PDF ↗ |
Product code NQN · Class II · Hematology. Data: openFDA.