Fluorometric Measurement, Porphyrins

Device Code: 478

Product Code(s): JKJ

Device Classification Information

• Device Type ID: 478
• Device Name: Fluorometric Measurement, Porphyrins
• Regulation Description: Porphyrins 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: 862.1595 [🔎]
• FDA Device Classification: Class 1 Medical Device
• Product Code: JKJ
• GMP Exempt: No
• Summary MR: Eligible
• Implanted Device: No
• Life Support Device: No
• Third Party Review: Not Third Party Eligible

Recognized Standards

• 7-21 CLSI C42-A
  Erythrocyte Protoporphyrin Testing; Approved Guideline

Total Product Life Cycle

• Device Type ID: 478
• Device: Fluorometric Measurement, Porphyrins
• Product Code: JKJ
• FDA Device Classification: Class 1 Medical Device
• Regulation Description: Porphyrins Test System.
• CFR Regulation Number: 862.1595 [🔎]

TPLC Last Update: 2019-04-02 19:35:26