Product Classification

• Device: activated whole blood clotting time
• Regulation Description: Activated whole blood clotting time tests.
• Regulation Medical Specialty: Hematology
• Review Panel: Hematology
• Product Code: JBP
• Submission Type: 510(k)
• Regulation Number: 864.7140
• Device Class: 2
• Total Product Life Cycle (TPLC): TPLC Product Code Report
• GMP Exempt?: No

Recognized Consensus Standards

• CLSI H49-A Point-of-Care Monitoring of Anticoagulant Therapy; Approved Guideline
• CLSI H49-A Point-of-Care Monitoring of Anticoagulation Therapy; Approved Guideline

Third Party Review

Not Third Party Eligible