The following data is part of a premarket notification filed by Bionostics, Inc. with the FDA for Oxyhemoglobin Control For Co-oximetry.
| Device ID | K980178 |
| 510k Number | K980178 |
| Device Name: | OXYHEMOGLOBIN CONTROL FOR CO-OXIMETRY |
| Classification | Multi-analyte Controls, All Kinds (assayed) |
| Applicant | BIONOSTICS, INC. 2 CRAIG RD. Acton, MA 01720 |
| Contact | Bruce R Williams |
| Correspondent | Bruce R Williams BIONOSTICS, INC. 2 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 | 1998-01-20 |
| Decision Date | 1998-02-12 |
| Summary: | summary |