The following data is part of a premarket notification filed by Bio-rad with the FDA for Lyphochek Whole Blood Metals Control Model # 527, 528, 529.
| Device ID | K020610 |
| 510k Number | K020610 |
| Device Name: | LYPHOCHEK WHOLE BLOOD METALS CONTROL MODEL # 527, 528, 529 |
| Classification | Heavy Metals Control Materials |
| Applicant | BIO-RAD 9500 JERONIMO RD. Irvine, CA 92618 |
| Contact | Yvette Lloyd |
| Correspondent | Yvette Lloyd BIO-RAD 9500 JERONIMO RD. Irvine, CA 92618 |
| Product Code | DIE |
| CFR Regulation Number | 862.3280 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-02-25 |
| Decision Date | 2002-04-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00847661001843 | K020610 | 000 |
| 00847661001706 | K020610 | 000 |
| 00847661001690 | K020610 | 000 |
| 00847661001683 | K020610 | 000 |