Product Classification

• Device: radio-labeled iron method, iron (non-heme)
• Regulation Description: Iron (non-heme) test system.
• Regulation Medical Specialty: Clinical Chemistry
• Review Panel: Clinical Chemistry
• Product Code: JJA
• Submission Type: Enforcement Discretion
• Regulation Number: 862.1410
• Device Class: 1
• Total Product Life Cycle (TPLC): TPLC Product Code Report
• GMP Exempt?: No

Third Party Review

• Eligible for Accredited Persons Program

Accredited Persons

• bsi healthcare
• center for measurement standards of industrial
• intertek testing services
• pharmalink technical group, llc
• regulatory technology services, llc
• tuv sud america inc.
• underwriters laboratories, inc.