The following data is part of a premarket notification filed by Canyon Diagnostics, Inc. with the FDA for Cantrol Hdl Cholesterol Precipi. Reag. And Tubes.
Device ID | K882488 |
510k Number | K882488 |
Device Name: | CANTROL HDL CHOLESTEROL PRECIPI. REAG. AND TUBES |
Classification | Ldl & Vldl Precipitation, Hdl |
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 | LBR |
CFR Regulation Number | 862.1475 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1988-06-16 |
Decision Date | 1988-08-15 |