OMNYX IDP FOR HER2 MANUAL APPLICATION
FDA 510(k) clearance K131140 · decided 2014-04-01
Clearance details
- K-number
- K131140
- Device name
- OMNYX IDP FOR HER2 MANUAL APPLICATION
- Applicant
- Omnyx, LLC
- Decision
- Substantially Equivalent
- Date received
- 2013-04-22
- Decision date
- 2014-04-01
- Days to decision
- 344 days
- Clearance type
- Traditional
- Product code
- OEO
- Device class
- 2
- Regulation number
- 864.1860
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- Location
- Marlborough, MA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Virtuoso System for IHC PR (1E2) using iScan HT (K142965) | Ventana Medical Systems, Inc. | 2015-07-16 |
| PHILIPS HERCEPTEST DIGITAL SCORE (K130021) | Philips Medical Systems Nederland B.V. | 2013-09-19 |
| VIRTUAL SLIDE SYSTEM, OLYMPUS VS800 SYSTEM (K111914) | Olympus America Inc. / Scientific Equipment Group | 2012-08-21 |
| SCANSCOPE XT SYSTEM (K080254) | Aperio Technologies | 2008-10-31 |
| SCANSCOPE XT SYSTEM (K071671) | Aperio Technologies | 2007-12-28 |
Recalls involving this device
No recalls on record reference this clearance.