The following data is part of a premarket notification filed by Bionostics, Inc. with the FDA for Rna Medical Glucose And B-ketone Calibration Verification Controls.
| Device ID | K081478 |
| 510k Number | K081478 |
| Device Name: | RNA MEDICAL GLUCOSE AND B-KETONE CALIBRATION VERIFICATION CONTROLS |
| Classification | Single (specified) Analyte Controls (assayed And Unassayed) |
| Applicant | BIONOSTICS, INC. 7 JACKSON RD. Devens, MA 01434 |
| Contact | Kathleen Storro |
| Correspondent | Kathleen Storro BIONOSTICS, INC. 7 JACKSON RD. Devens, MA 01434 |
| Product Code | JJX |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-05-27 |
| Decision Date | 2008-10-06 |
| Summary: | summary |