Product Classification

• Device: device, automated cell-locating
• Regulation Description: Automated cell-locating device.
• Regulation Medical Specialty: Hematology
• Review Panel: Hematology
• Product Code: JOY
• Premarket Review: Division of Immunology and Hematology Devices (DIHD); Division of Immunology and Hematology Devices (DIHD)
• Submission Type: 510(k)
• Regulation Number: 864.5260
• Device Class: 2
• Total Product Life Cycle (TPLC): TPLC Product Code Report
• GMP Exempt?: No
• Summary Malfunction Reporting: Eligible
• Implanted Device?: No
• Life-Sustain/Support Device?: No

Recognized Consensus Standard

• 7-165 CLSI H20-A2 (Replaces H20-A)
  Reference Leukocyte (WBC) Differential Count (Proportional) and Evaluation of Instrumental Methods; Approved Standard - Second Edition

Third Party Review

• Eligible for 510(k) Third Party Review Program

Accredited Persons

• aabb
• beanstock consulting
• global quality and regulatory services
• regulatory technology services, llc