The following data is part of a premarket notification filed by Canyon Diagnostics, Inc. with the FDA for Cantrol Serum Iron And Total Iron Binding Capacity Test System.
| Device ID | K970248 |
| 510k Number | K970248 |
| Device Name: | CANTROL SERUM IRON AND TOTAL IRON BINDING CAPACITY TEST SYSTEM |
| Classification | Resin, Ion-exchange, Ascorbic Acid, Colorimetry, Iron Binding Capacity |
| Applicant | CANYON DIAGNOSTICS, INC. 4075 LEAVERTON COURT Anaheim, CA 92807 |
| Contact | Anthony Falkowski |
| Correspondent | Anthony Falkowski CANYON DIAGNOSTICS, INC. 4075 LEAVERTON COURT Anaheim, CA 92807 |
| Product Code | JQE |
| CFR Regulation Number | 862.1415 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-01-22 |
| Decision Date | 1997-02-11 |
| Summary: | summary |