PureBMC SupraPhysiologic Concentrating System 30 mL System, PureBMC SupraPhysiologic Concentrating System 60 mL System, PureBMC SupraPhysiologic Concentrating System 120 mL System
FDA 510(k) clearance K183205 · decided 2019-05-30
Clearance details
- K-number
- K183205
- Device name
- PureBMC SupraPhysiologic Concentrating System 30 mL System, PureBMC SupraPhysiologic Concentrating System 60 mL System, PureBMC SupraPhysiologic Concentrating System 120 mL System
- Applicant
- Emcyte Corporation
- Decision
- Unknown
- Date received
- 2018-11-19
- Decision date
- 2019-05-30
- Days to decision
- 192 days
- Clearance type
- Special
- Product code
- JQC
- Device class
- 1
- Regulation number
- 862.2050
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Fort Meyers, FL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.