The following data is part of a premarket notification filed by Bionostics, Inc. with the FDA for Control For Ph,blood Gases,eletrolytes,glucose.
| Device ID | K911755 |
| 510k Number | K911755 |
| Device Name: | CONTROL FOR PH,BLOOD GASES,ELETROLYTES,GLUCOSE |
| Classification | Multi-analyte Controls, All Kinds (assayed) |
| Applicant | BIONOSTICS, INC. TWO CRAIG RD. Acton, MA 01720 |
| Contact | Bruce Williams |
| Correspondent | Bruce Williams BIONOSTICS, INC. TWO CRAIG RD. Acton, MA 01720 |
| Product Code | JJY |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-04-18 |
| Decision Date | 1991-05-22 |