The following data is part of a premarket notification filed by Canyon Diagnostics, Inc. with the FDA for Cantrol Electrophoresis Control.
Device ID | K854931 |
510k Number | K854931 |
Device Name: | CANTROL ELECTROPHORESIS CONTROL |
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 | 1985-12-10 |
Decision Date | 1986-01-17 |