PureBMC SupraPhysiologic Concentrating System 30 mL System, PureBMC SupraPhysiologic Concentrating System 60 mL System, PureBMC SupraPhysiologic Concentrating System 120 mL System— 510(k) K183205
UnknownEmcyte Corporation
FDA 510(k) clearance K183205 for PureBMC SupraPhysiologic Concentrating System 30 mL System, PureBMC SupraPhysiologic Concentrating System 60 mL System, PureBMC SupraPhysiologic Concentrating System 120 mL System, Unknown on 2019-05-30. Applicant: Emcyte Corporation.
Clearance details
- Applicant
- Emcyte Corporation
- Product code
- Code JQC
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Unknown
- Clearance type
- Special
- Location
- Fort Meyers, FL, US
Adverse events under product code JQC
product code JQC- Other
- 1
- Total
- 1
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.