Spectra Optia Apheresis System
FDA 510(k) clearance K153601 · decided 2016-01-14
Clearance details
- K-number
- K153601
- Device name
- Spectra Optia Apheresis System
- Applicant
- Terumobct, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2015-12-16
- Decision date
- 2016-01-14
- Days to decision
- 29 days
- Clearance type
- Special
- Product code
- LKN
- Device class
- U
- Medical specialty
- Unknown
- Advisory committee
- Unknown
- Location
- Lakewood, CO, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.