Fibrinogen Determination Standards And Controls

Device Code: 2246

Product Code(s): GFK

Device Classification Information

• Device Type ID: 2246
• Device Name: Fibrinogen Determination Standards And Controls
• Regulation Description: Fibrinogen Determination System.
• 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: 864.7340 [🔎]
• FDA Device Classification: Class 2 Medical Device
• Product Code: GFK
• GMP Exempt: No
• Summary MR: Eligible
• Implanted Device: No
• Life Support Device: No
• Third Party Review: Eligible For Accredited Persons Expansion Pilot Program

Recognized Standards

Total Product Life Cycle

• Device Type ID: 2246
• Device: Fibrinogen Determination Standards And Controls
• Product Code: GFK
• FDA Device Classification: Class 2 Medical Device
• Regulation Description: Fibrinogen Determination System.
• CFR Regulation Number: 864.7340 [🔎]

TPLC Last Update: 2019-04-02 20:08:18