The following data is part of a premarket notification filed by Bio-rad with the FDA for Lyphochek Hemostasis, Models 798, 799.
| Device ID | K020878 |
| 510k Number | K020878 |
| Device Name: | LYPHOCHEK HEMOSTASIS, MODELS 798, 799 |
| Classification | Control, Plasma, Abnormal |
| Applicant | BIO-RAD 9500 JERONIMO RD. Irvine, CA 92618 |
| Contact | Maria Zeballos |
| Correspondent | Maria Zeballos BIO-RAD 9500 JERONIMO RD. Irvine, CA 92618 |
| Product Code | GGC |
| CFR Regulation Number | 864.5425 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-03-18 |
| Decision Date | 2002-04-15 |
| Summary: | summary |