The following data is part of a premarket notification filed by Fujirebio Diagnostics Texas, Inc. with the FDA for Fdtx Glucose Control Solution.
| Device ID | K081915 |
| 510k Number | K081915 |
| Device Name: | FDTX GLUCOSE CONTROL SOLUTION |
| Classification | Single (specified) Analyte Controls (assayed And Unassayed) |
| Applicant | FUJIREBIO DIAGNOSTICS TEXAS, INC. 940 CROSSROADS BLVD. Seguin, TX 78155 |
| Contact | John Gormley |
| Correspondent | John Gormley FUJIREBIO DIAGNOSTICS TEXAS, 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 | 2008-07-03 |
| Decision Date | 2008-08-08 |
| Summary: | summary |