The following data is part of a premarket notification filed by Bionostics, Inc. with the FDA for Secondary Calibrators.
| Device ID | K904335 |
| 510k Number | K904335 |
| Device Name: | SECONDARY CALIBRATORS |
| Classification | Electrode, Ion Specific, Sodium |
| Applicant | BIONOSTICS, INC. TWO CRAIG RD. Acton, MA 01720 |
| Contact | Bruce R Williams |
| Correspondent | Bruce R Williams BIONOSTICS, INC. TWO CRAIG RD. Acton, MA 01720 |
| Product Code | JGS |
| CFR Regulation Number | 862.1665 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-09-20 |
| Decision Date | 1990-10-12 |