The following data is part of a premarket notification filed by Canyon Diagnostics, Inc. with the FDA for Cantrol Ck/mb Control.
| Device ID | K855006 |
| 510k Number | K855006 |
| Device Name: | CANTROL CK/MB CONTROL |
| Classification | Enzyme Controls (assayed And Unassayed) |
| Applicant | CANYON DIAGNOSTICS, INC. 4081 E. LA PALMA AVE., UNIT F Anaheim, CA 92807 |
| Contact | Falkowski |
| Correspondent | Falkowski CANYON DIAGNOSTICS, INC. 4081 E. LA PALMA AVE., UNIT F Anaheim, CA 92807 |
| Product Code | JJT |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-12-13 |
| Decision Date | 1986-01-17 |