# K964640: Cantrol Iron/Tibc Controls, Level 1 and Level 2 Product Numbers: Level 1: Iibc-91 and Level 2: Iibc-92

- Pathway: 510(k) (Traditional)
- Applicant: Canyon Diagnostics, Inc.
- Decided: Dec 13, 1996 after 24 days
- Product code: JJY (Multi-Analyte Controls, All Kinds (Assayed))
- Device class: 1
- Regulation: 21 CFR 862.1660
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Indications for use
CANTROL Iron /TIBC Controls provide a simple, but effective, method for the performance of intra- or inter- laboratory quality control in the quantitation of Serum Iron and Total Iron Binding Capacity.

Source page: https://510kreport.com/device/K964640
Methodology: https://510kreport.com/methodology