TOTAL IRON BINDING CAPACITY TEST

Resin, Ion-exchange, Ascorbic Acid, Colorimetry, 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: K884649
• 510k Number: K884649
• Device Name: TOTAL IRON BINDING CAPACITY TEST
• Classification: Resin, Ion-exchange, Ascorbic Acid, Colorimetry, Iron Binding Capacity
• Applicant: SCLAVO, INC. 5 MANSARD COURT Wayne, NJ 07470
• Contact: King, Ph.d.
• Correspondent: King, Ph.d.; SCLAVO, INC. 5 MANSARD COURT Wayne, NJ 07470
• Product Code: JQE
• CFR Regulation Number: 862.1415 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1988-11-07
• Decision Date: 1988-12-14