The following data is part of a premarket notification filed by Dade, Baxter Travenol Diagnostics, Inc. with the FDA for Whole Blood Gas Control, Levels 1,2,&3.
| Device ID | K800296 |
| 510k Number | K800296 |
| Device Name: | WHOLE BLOOD GAS CONTROL, LEVELS 1,2,&3 |
| Classification | Control, Hemoglobin |
| Applicant | DADE, BAXTER TRAVENOL DIAGNOSTICS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | GGM |
| CFR Regulation Number | 864.8625 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-02-11 |
| Decision Date | 1980-03-05 |