The following data is part of a premarket notification filed by Bio-rad Laboratories with the FDA for Lyphochek Diabetes Control.
| Device ID | K070546 |
| 510k Number | K070546 |
| Device Name: | LYPHOCHEK DIABETES CONTROL |
| Classification | Control, Hemoglobin |
| Applicant | Bio-Rad Laboratories 9500 JERONIMO RD. Irvine, CA 92618 -2017 |
| Contact | Elizabeth Platt |
| Correspondent | Elizabeth Platt Bio-Rad Laboratories 9500 JERONIMO RD. Irvine, CA 92618 -2017 |
| Product Code | GGM |
| CFR Regulation Number | 864.8625 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-02-26 |
| Decision Date | 2007-04-02 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00847661002185 | K070546 | 000 |
| 00847661000860 | K070546 | 000 |