Product Classification

• Device: instrument, coagulation
• Regulation Description: Coagulation instrument.
• Regulation Medical Specialty: Hematology
• Review Panel: Hematology
• Product Code: KQG
• Submission Type: 510(k)
• Regulation Number: 864.5400
• 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 Anticoagulation Therapy; Approved Guideline
• CLSI H49-A Point-of-Care Monitoring of Anticoagulant Therapy; Approved Guideline

Guidance Document

• 510(k) Submissions for Coagulation Instruments - Guidance for Industry and FDA Staff

Third Party Review

Not Third Party Eligible