The following data is part of a premarket notification filed by Bio-rad with the FDA for Lyphochek Hemostasis Control.
| Device ID | K040275 |
| 510k Number | K040275 |
| Device Name: | LYPHOCHEK HEMOSTASIS CONTROL |
| Classification | Plasma, Coagulation Control |
| Applicant | BIO-RAD 9500 JERONIMO RD. Irvine, CA 92618 |
| Contact | Elizabeth Platt |
| Correspondent | Elizabeth Platt BIO-RAD 9500 JERONIMO RD. Irvine, CA 92618 |
| Product Code | GGN |
| CFR Regulation Number | 864.5425 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-02-05 |
| Decision Date | 2004-02-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00847661001898 | K040275 | 000 |
| 00847661001041 | K040275 | 000 |
| 00847661001034 | K040275 | 000 |
| 00847661001027 | K040275 | 000 |