The following data is part of a premarket notification filed by Roche Diagnostics with the FDA for Precicontrol Hba1c Norm; Precicontrol Hba1c Path.
| Device ID | K103099 |
| 510k Number | K103099 |
| Device Name: | PRECICONTROL HBA1C NORM; PRECICONTROL HBA1C PATH |
| Classification | Single (specified) Analyte Controls (assayed And Unassayed) |
| Applicant | Roche Diagnostics 9115 HAGUE ROAD Indianapolis, IN 46250 -0416 |
| Contact | Susan Hollandbeck |
| Correspondent | Susan Hollandbeck Roche Diagnostics 9115 HAGUE ROAD Indianapolis, IN 46250 -0416 |
| Product Code | JJX |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-10-20 |
| Decision Date | 2010-12-06 |