Electrophoresis, Cholesterol Via Esterase-oxidase, Hdl

Device Code: 601

Product Code(s): LBT

Device Classification Information

• Device Type ID: 601
• Device Name: Electrophoresis, Cholesterol Via Esterase-oxidase, Hdl
• Regulation Description: Lipoprotein 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: 862.1475 [🔎]
• FDA Device Classification: Class 1 Medical Device
• Product Code: LBT
• 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: 601
• Device: Electrophoresis, Cholesterol Via Esterase-oxidase, Hdl
• Product Code: LBT
• FDA Device Classification: Class 1 Medical Device
• Regulation Description: Lipoprotein Test System.
• CFR Regulation Number: 862.1475 [🔎]

TPLC Last Update: 2019-04-02 19:37:09