The following data is part of a premarket notification filed by Roche Diagnostics Corp. with the FDA for Accu-chek Performa System.
| Device ID | K070585 |
| 510k Number | K070585 |
| Device Name: | ACCU-CHEK PERFORMA SYSTEM |
| Classification | System, Test, Blood Glucose, Over The Counter |
| Applicant | ROCHE DIAGNOSTICS CORP. 9115 HAGUE RD. Indianapolis, IN 46250 |
| Contact | Scott Thiel |
| Correspondent | Scott Thiel ROCHE DIAGNOSTICS CORP. 9115 HAGUE RD. 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 | 2007-03-01 |
| Decision Date | 2007-05-25 |
| Summary: | summary |