Kinetic Method, Gamma-glutamyl Transpeptidase

Device Code: 550

Product Code(s): JQB

Device Classification Information

• Device Type ID: 550
• Device Name: Kinetic Method, Gamma-glutamyl Transpeptidase
• Regulation Description: Gamma-glutamyl Transpeptidase And Isoenzymes Test System.
• Regulation Medical Specialty: Clinical Chemistry
• Review Panel: Clinical Chemistry
• Premarket Review: Office Of In Vitro Diagnostics And Radiological Health (OIR)
• Submission Type: 510(K) Exempt
• CFR Regulation Number: 862.1360 [🔎]
• FDA Device Classification: Class 1 Medical Device
• Product Code: JQB
• GMP Exempt: No
• Summary MR: Eligible
• Implanted Device: No
• Life Support Device: No
• Third Party Review: Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

• Device Type ID: 550
• Device: Kinetic Method, Gamma-glutamyl Transpeptidase
• Product Code: JQB
• FDA Device Classification: Class 1 Medical Device
• Regulation Description: Gamma-glutamyl Transpeptidase And Isoenzymes Test System.
• CFR Regulation Number: 862.1360 [🔎]

Device Problems
High Test Results	1
Total Device Problems	1

TPLC Last Update: 2019-04-02 19:36:21