The following data is part of a premarket notification filed by Bio-rad Laboratories with the FDA for Liquidchek Diabetes Control; Level 1, Level 2, Level 3, Trilevel Minipak.
| Device ID | K123798 |
| 510k Number | K123798 |
| Device Name: | LIQUIDCHEK DIABETES CONTROL; LEVEL 1, LEVEL 2, LEVEL 3, TRILEVEL MINIPAK |
| Classification | Single (specified) Analyte Controls (assayed And Unassayed) |
| Applicant | Bio-Rad Laboratories 9500 JERONIMO RD. Irvine, CA 92618 -2017 |
| Contact | Suzanne Parsons |
| Correspondent | Suzanne Parsons Bio-Rad Laboratories 9500 JERONIMO RD. Irvine, CA 92618 -2017 |
| Product Code | JJX |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-12-10 |
| Decision Date | 2013-01-09 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00847661004301 | K123798 | 000 |
| 00847661004295 | K123798 | 000 |
| 00847661004288 | K123798 | 000 |
| 00847661004271 | K123798 | 000 |