Acid, Uric, Phosphotungstate Reduction

Device Code: 245

Product Code(s): CDH

Device Classification Information

• Device Type ID: 245
• Device Name: Acid, Uric, Phosphotungstate Reduction
• Regulation Description: Uric Acid 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: 862.1775 [🔎]
• FDA Device Classification: Class 1 Medical Device
• Product Code: CDH
• 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: 245
• Device: Acid, Uric, Phosphotungstate Reduction
• Product Code: CDH
• FDA Device Classification: Class 1 Medical Device
• Regulation Description: Uric Acid Test System.
• CFR Regulation Number: 862.1775 [🔎]

Device Problems
Low Test Results	1
Adverse Event Without Identified Device Or Use Problem	1
Total Device Problems	2

TPLC Last Update: 2019-04-02 19:31:15