Ferrozine (colorimetric) Iron Binding Capacity

Device Code: 518

Product Code(s): JMO

Device Classification Information

• Device Type ID: 518
• Device Name: Ferrozine (colorimetric) Iron Binding Capacity
• Regulation Description: Iron-binding Capacity 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: 862.1415 [🔎]
• FDA Device Classification: Class 1 Medical Device
• Product Code: JMO
• 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: 518
• Device: Ferrozine (colorimetric) Iron Binding Capacity
• Product Code: JMO
• FDA Device Classification: Class 1 Medical Device
• Regulation Description: Iron-binding Capacity Test System.
• CFR Regulation Number: 862.1415 [🔎]

Recalls
Manufacturer		Recall Class	Date Posted
1	Ortho-Clinical Diagnostics	III	Jul-01-2016

TPLC Last Update: 2019-04-02 19:35:54