System, Test, C-reactive Protein, Rhodamine

Device Code: 2925

Product Code(s): DCH

Device Classification Information

• Device Type ID: 2925
• Device Name: System, Test, C-reactive Protein, Rhodamine
• Regulation Description: C-reactive Protein Immunological Test System.
• Regulation Medical Specialty: Immunology
• Review Panel: Immunology
• Premarket Review: Office Of In Vitro Diagnostics And Radiological Health (OIR)
• Submission Type: 510(k)
• CFR Regulation Number: 866.5270 [🔎]
• FDA Device Classification: Class 2 Medical Device
• Product Code: DCH
• 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: 2925
• Device: System, Test, C-reactive Protein, Rhodamine
• Product Code: DCH
• FDA Device Classification: Class 2 Medical Device
• Regulation Description: C-reactive Protein Immunological Test System.
• CFR Regulation Number: 866.5270 [🔎]

TPLC Last Update: 2019-04-02 20:21:17