Radio-labeled Iron Method, Iron (non-heme)

Device Code: 449

Product Code(s): JJA

Device Classification Information

• Device Type ID: 449
• Device Name: Radio-labeled Iron Method, Iron (non-heme)
• Regulation Description: Iron (non-heme) 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: 862.1410 [🔎]
• FDA Device Classification: Class 1 Medical Device
• Product Code: JJA
• GMP Exempt: No
• Summary MR: Eligible
• Implanted Device: No
• Life Support Device: No
• Third Party Review: Eligible For Accredited Persons Program

Recognized Standards

Total Product Life Cycle

• Device Type ID: 449
• Device: Radio-labeled Iron Method, Iron (non-heme)
• Product Code: JJA
• FDA Device Classification: Class 1 Medical Device
• Regulation Description: Iron (non-heme) Test System.
• CFR Regulation Number: 862.1410 [🔎]

TPLC Last Update: 2019-04-02 19:34:50