The following data is part of a premarket notification filed by Fujirebio Diagnostics, Inc with the FDA for Fdi Glucose Control Solution For Freestyle.
| Device ID | K103450 |
| 510k Number | K103450 |
| Device Name: | FDI GLUCOSE CONTROL SOLUTION FOR FREESTYLE |
| Classification | Single (specified) Analyte Controls (assayed And Unassayed) |
| Applicant | FUJIREBIO DIAGNOSTICS, INC 940 CROSSROADS BLVD. Seguin, TX 78155 |
| Contact | Kent Pruett |
| Correspondent | Kent Pruett FUJIREBIO DIAGNOSTICS, INC 940 CROSSROADS BLVD. Seguin, TX 78155 |
| Product Code | JJX |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-11-24 |
| Decision Date | 2011-01-25 |
| Summary: | summary |