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 |