Separator, Semi-automated, Blood Component

Device Code: 2495

Product Code(s): MYY

Device Classification Information

• Device Type ID: 2495
• Device Name: Separator, Semi-automated, Blood Component
• Review Panel: Hematology
• Premarket Review: Center For Biologics Evaluation & Research (CBER)
• Submission Type: 510(k)
• FDA Device Classification: Class 1 Medical Device
• Product Code: MYY
• GMP Exempt: No
• Summary MR: Eligible
• Implanted Device: No
• Life Support Device: No
• Third Party Review: Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

• Device Type ID: 2495
• Device: Separator, Semi-automated, Blood Component
• Product Code: MYY
• FDA Device Classification: Class 1 Medical Device

TPLC Last Update: 2019-04-02 20:13:20