Hexane Extraction, Fluorescence, Vitamin E

Device Code: 546

Product Code(s): JOB

Device Classification Information

• Device Type ID: 546
• Device Name: Hexane Extraction, Fluorescence, Vitamin E
• Regulation Description: Vitamin E 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: 862.1815 [🔎]
• FDA Device Classification: Class 1 Medical Device
• Product Code: JOB
• 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: 546
• Device: Hexane Extraction, Fluorescence, Vitamin E
• Product Code: JOB
• FDA Device Classification: Class 1 Medical Device
• Regulation Description: Vitamin E Test System.
• CFR Regulation Number: 862.1815 [🔎]

TPLC Last Update: 2019-04-02 19:36:17