PHILIPS HERCEPTEST DIGITAL SCORE
FDA 510(k) clearance K130021 · decided 2013-09-19
Clearance details
- K-number
- K130021
- Device name
- PHILIPS HERCEPTEST DIGITAL SCORE
- Applicant
- Philips Medical Systems Nederland B.V.
- Decision
- Substantially Equivalent
- Date received
- 2013-01-03
- Decision date
- 2013-09-19
- Days to decision
- 259 days
- Clearance type
- Traditional
- Product code
- OEO
- Device class
- 2
- Regulation number
- 864.1860
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- Location
- Best Noord-Brabant, NL
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Philips Medical Systems Nederland B.V.
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
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 |
| OMNYX IDP FOR HER2 MANUAL APPLICATION (K131140) | Omnyx, LLC | 2014-04-01 |
| 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.