IRON BINDING CAPACITY CHEMISTRY

Ferrozine (colorimetric) Iron Binding Capacity

HARLECO

The following data is part of a premarket notification filed by Harleco with the FDA for Iron Binding Capacity Chemistry.

Pre-market Notification Details

• Device ID: K780094
• 510k Number: K780094
• Device Name: IRON BINDING CAPACITY CHEMISTRY
• Classification: Ferrozine (colorimetric) Iron Binding Capacity
• Applicant: HARLECO 803 N. Front St. Suite 3 Mchenry, IL 60050
• Product Code: JMO
• CFR Regulation Number: 862.1415 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1978-01-18
• Decision Date: 1978-02-13