Product Classification

• Device: test, thrombin time
• Regulation Description: Thrombin time test.
• Regulation Medical Specialty: Hematology
• Review Panel: Hematology
• Product Code: GJA
• Submission Type: 510(k)
• Regulation Number: 864.7875
• Device Class: 2
• Total Product Life Cycle (TPLC): TPLC Product Code Report
• GMP Exempt?: No

Recognized Consensus Standard

• CLSI H21-A5 Collection, Transport, and Processing of Blood Specimens for Testing Plasma-Based Coagulation Assays and Molecular Hemostasis Assays

Third Party Review

Not Third Party Eligible