The following data is part of a premarket notification filed by Bionostics, Inc. with the FDA for Glucose Meter-check Control Solution For Roche Accu-chek.
| Device ID | K081403 |
| 510k Number | K081403 |
| Device Name: | GLUCOSE METER-CHECK CONTROL SOLUTION FOR ROCHE ACCU-CHEK |
| Classification | Single (specified) Analyte Controls (assayed And Unassayed) |
| Applicant | BIONOSTICS, INC. 7 JACKSON RD. Devens, MA 01434 |
| Contact | Randy Byrd |
| Correspondent | Randy Byrd 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 | 2008-05-19 |
| Decision Date | 2008-07-25 |
| Summary: | summary |