The following data is part of a premarket notification filed by Canyon Diagnostics, Inc. with the FDA for Cantrol Urine Dipstick Control Two Levels.
Device ID | K853603 |
510k Number | K853603 |
Device Name: | CANTROL URINE DIPSTICK CONTROL TWO LEVELS |
Classification | Urinalysis 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 | JJW |
CFR Regulation Number | 862.1660 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1985-08-28 |
Decision Date | 1985-10-08 |