The following data is part of a premarket notification filed by Bionostics, Inc. with the FDA for Multi-function Blood Gas Control.
| Device ID | K874408 |
| 510k Number | K874408 |
| Device Name: | MULTI-FUNCTION BLOOD GAS CONTROL |
| Classification | Controls For Blood-gases, (assayed And Unassayed) |
| Applicant | BIONOSTICS, INC. TWO CRAIG RD. Acton, MA 01720 |
| Contact | R Williams |
| Correspondent | R Williams BIONOSTICS, INC. TWO CRAIG RD. Acton, MA 01720 |
| Product Code | JJS |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-10-28 |
| Decision Date | 1987-12-14 |