The following data is part of a premarket notification filed by Bionostics, Inc. with the FDA for Ph Electrode Calibrating Buffers-blood.
| Device ID | K840299 |
| 510k Number | K840299 |
| Device Name: | PH ELECTRODE CALIBRATING BUFFERS-BLOOD |
| Classification | Calibrator, Primary |
| Applicant | BIONOSTICS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | JIS |
| CFR Regulation Number | 862.1150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-01-24 |
| Decision Date | 1984-03-23 |