The following data is part of a premarket notification filed by Bionostics, Inc. with the FDA for Blood Gas Control, Level I(acidosis.
| Device ID | K841783 |
| 510k Number | K841783 |
| Device Name: | BLOOD GAS CONTROL, LEVEL I(ACIDOSIS |
| Classification | Controls For Blood-gases, (assayed And Unassayed) |
| Applicant | BIONOSTICS, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | JJS |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-04-30 |
| Decision Date | 1984-06-14 |