Tetraphenyl Borate, Colorimetry, Potassium

Device Code: 265

Product Code(s): CEJ

Device Classification Information

• Device Type ID: 265
• Device Name: Tetraphenyl Borate, Colorimetry, Potassium
• 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: CEJ
• GMP Exempt: No
• Summary MR: Eligible
• Implanted Device: No
• Life Support Device: No
• Third Party Review: Eligible For Accredited Persons Program

Recognized Standards

Total Product Life Cycle

• Device Type ID: 265
• Device: Tetraphenyl Borate, Colorimetry, Potassium
• Product Code: CEJ
• FDA Device Classification: Class 2 Medical Device
• Regulation Description: Potassium Test System.
• CFR Regulation Number: 862.1600 [🔎]

TPLC Last Update: 2019-04-02 19:31:50