Biosensor, Immunoassay, Cpk Or Isoenzymes

Device Code: 622

Product Code(s): MYT

Device Classification Information

• Device Type ID: 622
• Device Name: Biosensor, Immunoassay, Cpk Or Isoenzymes
• Regulation Description: Creatine Phosphokinase/creatine Kinase Or 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)
• CFR Regulation Number: 862.1215 [🔎]
• FDA Device Classification: Class 2 Medical Device
• Product Code: MYT
• 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: 622
• Device: Biosensor, Immunoassay, Cpk Or Isoenzymes
• Product Code: MYT
• FDA Device Classification: Class 2 Medical Device
• Regulation Description: Creatine Phosphokinase/creatine Kinase Or Isoenzymes Test System.
• CFR Regulation Number: 862.1215 [🔎]

Device Problems
Incorrect, Inadequate Or Imprecise Result Or Readings	1
Total Device Problems	1

TPLC Last Update: 2019-04-02 19:37:34