The following data is part of a premarket notification filed by Bionostics, Inc. with the FDA for Aqueous Blood Gas Control.
| Device ID | K833146 |
| 510k Number | K833146 |
| Device Name: | AQUEOUS BLOOD GAS CONTROL |
| Classification | Controls For Blood-gases, (assayed And Unassayed) |
| Applicant | BIONOSTICS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | JJS |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-09-15 |
| Decision Date | 1983-11-28 |