Test, System, Potassium, Enzymatic Method

Device Code: 624

Product Code(s): MZV

Device Classification Information

• Device Type ID: 624
• Device Name: Test, System, Potassium, Enzymatic Method
• Regulation Description: Potassium 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: 862.1600 [🔎]
• FDA Device Classification: Class 2 Medical Device
• Product Code: MZV
• GMP Exempt: No
• Summary MR: Ineligible
• Implanted Device: No
• Life Support Device: No
• Third Party Review: Eligible For Accredited Persons Program

Recognized Standards

Total Product Life Cycle

• Device Type ID: 624
• Device: Test, System, Potassium, Enzymatic Method
• Product Code: MZV
• FDA Device Classification: Class 2 Medical Device
• Regulation Description: Potassium Test System.
• CFR Regulation Number: 862.1600 [🔎]

Device Problems
Incorrect, Inadequate Or Imprecise Result Or Readings	2
Total Device Problems	2

TPLC Last Update: 2019-04-02 19:37:35