FDA Product Code
FDA Product Code OEO — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Hematology
- 21 CFR Citation
- 864.1860
510(k) Clearances — 6 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K142965 | Virtuoso System for IHC PR (1E2) using iScan HT | Ventana Medical Systems, Inc. | 2015-07-16 | Traditional | PDF ↗ |
| K131140 | OMNYX IDP FOR HER2 MANUAL APPLICATION | Omnyx, LLC | 2014-04-01 | Traditional | PDF ↗ |
| K130021 | PHILIPS HERCEPTEST DIGITAL SCORE | Philips Medical Systems Nederland B.V. | 2013-09-19 | Traditional | PDF ↗ |
| K111914 | VIRTUAL SLIDE SYSTEM, OLYMPUS VS800 SYSTEM | Olympus America Inc. / Scientific Equipment Group | 2012-08-21 | Traditional | PDF ↗ |
| K080254 | SCANSCOPE XT SYSTEM | Aperio Technologies | 2008-10-31 | Traditional | PDF ↗ |
| K071671 | SCANSCOPE XT SYSTEM | Aperio Technologies | 2007-12-28 | Traditional | PDF ↗ |
Product code OEO · Class II · Hematology. Data: openFDA.