The following data is part of a premarket notification filed by Bio-rad with the FDA for Lyphochek Tumor Marker Control, Levels 1 And 2, 2ml, Model 580.
| Device ID | K011579 |
| 510k Number | K011579 |
| Device Name: | LYPHOCHEK TUMOR MARKER CONTROL, LEVELS 1 AND 2, 2ML, MODEL 580 |
| Classification | Multi-analyte Controls, All Kinds (assayed) |
| Applicant | BIO-RAD 9500 JERONIMO RD. Irvine, CA 92618 -2017 |
| Contact | Yvette Lloyd |
| Correspondent | Yvette Lloyd BIO-RAD 9500 JERONIMO RD. Irvine, CA 92618 -2017 |
| Product Code | JJY |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-05-22 |
| Decision Date | 2001-06-26 |
| Summary: | summary |