The following data is part of a premarket notification filed by Fujirebio Diagnostics, Inc. with the FDA for Fdi Level I And Level Ii Glucose Controls For The Embrace No Code.
| Device ID | K133197 |
| 510k Number | K133197 |
| Device Name: | FDI LEVEL I AND LEVEL II GLUCOSE CONTROLS FOR THE EMBRACE NO CODE |
| 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 | 2013-10-17 |
| Decision Date | 2014-01-17 |
| Summary: | summary |