The following data is part of a premarket notification filed by Canyon Diagnostics, Inc. with the FDA for Cantrol Iron/tibc Controls, Level 1 And Level 2 Product Numbers: Level 1: Iibc-91 And Level 2: Iibc-92.
| Device ID | K964640 |
| 510k Number | K964640 |
| Device Name: | CANTROL IRON/TIBC CONTROLS, LEVEL 1 AND LEVEL 2 PRODUCT NUMBERS: LEVEL 1: IIBC-91 AND LEVEL 2: IIBC-92 |
| Classification | Multi-analyte Controls, All Kinds (assayed) |
| 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 | JJY |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-11-19 |
| Decision Date | 1996-12-13 |
| Summary: | summary |