The following data is part of a premarket notification filed by Bio-rad with the FDA for Liquichek Diabetes Control, Level 1,2,3,4.
| Device ID | K052838 |
| 510k Number | K052838 |
| Device Name: | LIQUICHEK DIABETES CONTROL, LEVEL 1,2,3,4 |
| Classification | Control, Hemoglobin |
| Applicant | BIO-RAD 9500 JERONIMO RD. Irvine, CA 92618 -2017 |
| Contact | Maria Zeballos |
| Correspondent | Maria Zeballos 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 | 2005-10-07 |
| Decision Date | 2005-11-09 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00847661002192 | K052838 | 000 |
| 00847661000853 | K052838 | 000 |
| 00847661000846 | K052838 | 000 |
| 00847661000839 | K052838 | 000 |