The following data is part of a premarket notification filed by Bionostics, Inc. with the FDA for Multi-meter Glucose Calibration Verification Material, Model Rna Gl3.
| Device ID | K012430 |
| 510k Number | K012430 |
| Device Name: | MULTI-METER GLUCOSE CALIBRATION VERIFICATION MATERIAL, MODEL RNA GL3 |
| Classification | Single (specified) Analyte Controls (assayed And Unassayed) |
| Applicant | BIONOSTICS, INC. 2 CRAIG RD. Acton, MA 01720 |
| Contact | Kathy Storro |
| Correspondent | Kathy 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 | 2001-07-31 |
| Decision Date | 2001-08-27 |
| Summary: | summary |