The following data is part of a premarket notification filed by Bio-rad with the FDA for Liquichek Blood Gas Plus E Control, Model 576, 577, 578.
| Device ID | K002865 |
| 510k Number | K002865 |
| Device Name: | LIQUICHEK BLOOD GAS PLUS E CONTROL, MODEL 576, 577, 578 |
| Classification | Controls For Blood-gases, (assayed And Unassayed) |
| 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 | JJS |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-09-13 |
| Decision Date | 2000-09-25 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00847661003656 | K002865 | 000 |
| 00847661003649 | K002865 | 000 |
| 00847661003632 | K002865 | 000 |
| 00847661003625 | K002865 | 000 |