The following data is part of a premarket notification filed by Roche Diagnostics with the FDA for Accu-chek Performa Blood Glucose Monitoring System.
| Device ID | K133741 |
| 510k Number | K133741 |
| Device Name: | ACCU-CHEK Performa Blood Glucose Monitoring System |
| Classification | System, Test, Blood Glucose, Over The Counter |
| Applicant | Roche Diagnostics 9115 Hague Road Indianapolis, IN 46250 |
| Contact | Nathan Carrington |
| Correspondent | Nathan Carrington Roche Diagnostics 9115 Hague Road Indianapolis, IN 46250 |
| Product Code | NBW |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-12-09 |
| Decision Date | 2014-08-29 |
| Summary: | summary |