The following data is part of a premarket notification filed by Canyon Diagnostics, Inc. with the FDA for Cantrol Hdl Cholestrol Controls Levels I And Ii.
| Device ID | K871537 |
| 510k Number | K871537 |
| Device Name: | CANTROL HDL CHOLESTROL CONTROLS LEVELS I AND II |
| Classification | Multi-analyte Controls, All Kinds (assayed) |
| 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 | JJY |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-04-20 |
| Decision Date | 1987-05-06 |