The following data is part of a premarket notification filed by Bio-rad with the FDA for Lyphochek Hemoglobin Alc Linearity Set.
| Device ID | K003030 |
| 510k Number | K003030 |
| Device Name: | LYPHOCHEK HEMOGLOBIN ALC LINEARITY SET |
| Classification | Control, Hemoglobin |
| Applicant | BIO-RAD 9500 JERONIMO RD. Irvine, CA 92618 -2017 |
| Contact | Elizabeth Platt |
| Correspondent | Elizabeth Platt BIO-RAD 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 | 2000-09-28 |
| Decision Date | 2000-11-29 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00847661005698 | K003030 | 000 |