Timer, Clot, Automated

Device Code: 2313

Product Code(s): GKN

Device Classification Information

• Device Type ID: 2313
• Device Name: Timer, Clot, Automated
• Regulation Description: Coagulation Instrument.
• Regulation Medical Specialty: Hematology
• Review Panel: Hematology
• Premarket Review: Office Of In Vitro Diagnostics And Radiological Health (OIR)
• Submission Type: 510(k)
• CFR Regulation Number: 864.5400 [🔎]
• FDA Device Classification: Class 2 Medical Device
• Product Code: GKN
• GMP Exempt: No
• Summary MR: Eligible
• Implanted Device: No
• Life Support Device: No
• Third Party Review: Not Third Party Eligible

Recognized Standards

• 7-112 CLSI POCT14-A (Formerly H49-A)
  Point-of-Care Monitoring Of Anticoagulation Therapy; Approved Guideline

Total Product Life Cycle

• Device Type ID: 2313
• Device: Timer, Clot, Automated
• Product Code: GKN
• FDA Device Classification: Class 2 Medical Device
• Regulation Description: Coagulation Instrument.
• CFR Regulation Number: 864.5400 [🔎]

Device Problems
Insufficient Information	3
Material Deformation	1
Device Operates Differently Than Expected	1
Total Device Problems	5

TPLC Last Update: 2019-04-02 20:09:28