Atp And Creatine Kinase (enzymatic), Creatine

Device Code: 487

Product Code(s): JLB

Device Classification Information

• Device Type ID: 487
• Device Name: Atp And Creatine Kinase (enzymatic), Creatine
• Regulation Description: Creatine 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: 862.1210 [🔎]
• FDA Device Classification: Class 1 Medical Device
• Product Code: JLB
• 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: 487
• Device: Atp And Creatine Kinase (enzymatic), Creatine
• Product Code: JLB
• FDA Device Classification: Class 1 Medical Device
• Regulation Description: Creatine Test System.
• CFR Regulation Number: 862.1210 [🔎]

TPLC Last Update: 2019-04-02 19:35:32