Lipoprotein, High Density, Hdl, Over The Counter

Device Code: 628

Product Code(s): NAQ

Device Classification Information

• Device Type ID: 628
• Device Name: Lipoprotein, High Density, Hdl, Over The Counter
• Regulation Description: Cholesterol (total) 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: 862.1175 [🔎]
• FDA Device Classification: Class 1 Medical Device
• Product Code: NAQ
• GMP Exempt: No
• Summary MR: Eligible
• Implanted Device: No
• Life Support Device: No
• Third Party Review: Not Third Party Eligible

Recognized Standards

• 7-88 CLSI C37-A
  Preparation And Validation Of Commutable Frozen Human Serum Pools As Secondary Reference Materials For Cholesterol Measurement Procedures; Approved Guideline

Total Product Life Cycle

• Device Type ID: 628
• Device: Lipoprotein, High Density, Hdl, Over The Counter
• Product Code: NAQ
• FDA Device Classification: Class 1 Medical Device
• Regulation Description: Cholesterol (total) Test System.
• CFR Regulation Number: 862.1175 [🔎]

TPLC Last Update: 2019-04-02 19:37:38