FDA 510(k)
FDA class 1
Unknown
🇺🇸 United States
PureBMC SupraPhysiologic Concentrating System 30 mL System, PureBMC SupraPhysiologic Concentrating System 60 mL System, PureBMC SupraPhysiologic Concentrating System 120 mL System
K Number: K183205
·
Decision May 30, 2019
Classifications
1
FEI Numbers
164
Registration Numbers
164
Same Product Code
37
Applicant Total
1
Review Days
192
Basic Information
- Device Name
- PureBMC SupraPhysiologic Concentrating System 30 mL System, PureBMC SupraPhysiologic Concentrating System 60 mL System, PureBMC SupraPhysiologic Concentrating System 120 mL System
- K Number
- K183205
- Device Class
- FDA class 1
- Clearance Type
- Special
- Regulation Number
- 862.2050
- Medical Specialty
- Clinical Chemistry
- Decision
- Unknown
- Statement or Summary
- Statement
- Applicant
- EmCyte Corporation
- Date Received
- November 19, 2018
- Decision Date
- May 30, 2019
- Product Code
- JQC
- Advisory Committee
- Clinical Chemistry
- Review Advisory Committee
- HE
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| JQC | Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use | FDA class 1 | Clinical Chemistry |
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