Turbidimetric, Total Protein

Device Code: 401

Product Code(s): JGQ

Device Classification Information

• Device Type ID: 401
• Device Name: Turbidimetric, Total Protein
• Regulation Description: Total Protein 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: 862.1635 [🔎]
• FDA Device Classification: Class 2 Medical Device
• Product Code: JGQ
• GMP Exempt: No
• Summary MR: Eligible
• Implanted Device: No
• Life Support Device: No
• Third Party Review: Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

• Device Type ID: 401
• Device: Turbidimetric, Total Protein
• Product Code: JGQ
• FDA Device Classification: Class 2 Medical Device
• Regulation Description: Total Protein Test System.
• CFR Regulation Number: 862.1635 [🔎]

Device Problems
High Test Results	10
Mechanical Problem	6
Low Test Results	4
Device Issue	3
Insufficient Information	1
Probe	1
Total Device Problems	25

TPLC Last Update: 2019-04-02 19:34:05