The following data is part of a premarket notification filed by Bio-rad with the FDA for Liquichek Blood Gas Plus Co-oximeter Control, Models 637, 638, 639 (radiometer).
| Device ID | K002536 |
| 510k Number | K002536 |
| Device Name: | LIQUICHEK BLOOD GAS PLUS CO-OXIMETER CONTROL, MODELS 637, 638, 639 (RADIOMETER) |
| 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 | 2000-08-16 |
| Decision Date | 2000-08-30 |