Diacetyl-monoxime, Urea Nitrogen

Device Code: 256

Product Code(s): CDW

Device Classification Information

• Device Type ID: 256
• Device Name: Diacetyl-monoxime, Urea Nitrogen
• Regulation Description: Urea Nitrogen 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: 862.1770 [🔎]
• FDA Device Classification: Class 2 Medical Device
• Product Code: CDW
• 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: 256
• Device: Diacetyl-monoxime, Urea Nitrogen
• Product Code: CDW
• FDA Device Classification: Class 2 Medical Device
• Regulation Description: Urea Nitrogen Test System.
• CFR Regulation Number: 862.1770 [🔎]

Device Problems
Use Of Device Problem	1
Total Device Problems	1

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