The following data is part of a premarket notification filed by Bio-rad with the FDA for Liquichek Blood Gas Plus Co-oximeter Control (il Synthesis Series) Levels 1,2, And 3, Models 667,668,669.
| Device ID | K022529 |
| 510k Number | K022529 |
| Device Name: | LIQUICHEK BLOOD GAS PLUS CO-OXIMETER CONTROL (IL SYNTHESIS SERIES) LEVELS 1,2, AND 3, MODELS 667,668,669 |
| Classification | Controls For Blood-gases, (assayed And Unassayed) |
| Applicant | BIO-RAD 9500 JERONIMO RD. Irvine, CA 92618 |
| Contact | Elizabeth Platt |
| Correspondent | Elizabeth Platt BIO-RAD 9500 JERONIMO RD. Irvine, CA 92618 |
| Product Code | JJS |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-07-31 |
| Decision Date | 2002-08-15 |
| Summary: | summary |