TOTAL IRON BINDING CAPACITY TEST

Bathophenanthroline, Iron Binding Capacity

SCLAVO, INC.

The following data is part of a premarket notification filed by Sclavo, Inc. with the FDA for Total Iron Binding Capacity Test.

Pre-market Notification Details

• Device ID: K830032
• 510k Number: K830032
• Device Name: TOTAL IRON BINDING CAPACITY TEST
• Classification: Bathophenanthroline, Iron Binding Capacity
• Applicant: SCLAVO, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050
• Product Code: JQF
• CFR Regulation Number: 862.1415 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1983-01-07
• Decision Date: 1983-01-28