Product Classification

• Device: colorimetric method, lecithin/sphingomyelin ratio
• Regulation Description: Lecithin/sphingomyelin ratio in amniotic fluid test system.
• Regulation Medical Specialty: Clinical Chemistry
• Review Panel: Clinical Chemistry
• Product Code: JHF
• Submission Type: 510(k)
• Regulation Number: 862.1455
• Device Class: 2
• Total Product Life Cycle (TPLC): TPLC Product Code Report
• GMP Exempt?: No

Third Party Review

• Eligible for Accredited Persons Expansion Pilot Program

Accredited Persons

• dekra certification b.v.
• intertek testing services
• regulatory technology services, llc
• tuv sud america inc.
• underwriters laboratories, inc.