The following data is part of a premarket notification filed by Bionostics, Inc. with the FDA for Bionostics Glucose Quality Control Solution For Use With Medisense Blood Glucose Test Strip Systems.
| Device ID | K002540 |
| 510k Number | K002540 |
| Device Name: | BIONOSTICS GLUCOSE QUALITY CONTROL SOLUTION FOR USE WITH MEDISENSE BLOOD GLUCOSE TEST STRIP SYSTEMS |
| Classification | Single (specified) Analyte Controls (assayed And Unassayed) |
| Applicant | BIONOSTICS, INC. 2 CRAIG RD. Acton, MA 01720 |
| Contact | Kathleen Storro |
| Correspondent | Kathleen Storro BIONOSTICS, INC. 2 CRAIG RD. Acton, MA 01720 |
| Product Code | JJX |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-08-16 |
| Decision Date | 2000-09-18 |