Philips IntelliSite Pathology Solution
FDA 510(k) clearance DEN160056 · decided 2017-04-12
Clearance details
- K-number
- DEN160056
- Device name
- Philips IntelliSite Pathology Solution
- Applicant
- Philips Medical Systems Nederland B.V.
- Decision
- Unknown
- Date received
- 2016-12-01
- Decision date
- 2017-04-12
- Days to decision
- 132 days
- Clearance type
- Direct
- Product code
- PSY
- Device class
- 2
- Regulation number
- 864.3700
- Medical specialty
- Pathology
- Advisory committee
- Pathology
- Location
- Best, NL
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.