The following data is part of a premarket notification filed by Roche Diagnostics Corp. with the FDA for Modification To Accu-chek Go System.
| Device ID | K051592 |
| 510k Number | K051592 |
| Device Name: | MODIFICATION TO ACCU-CHEK GO SYSTEM |
| Classification | Glucose Dehydrogenase, Glucose |
| Applicant | ROCHE DIAGNOSTICS CORP. 9115 HAGUE RD. Indianapolis, IN 46250 -0457 |
| Contact | Dimitris Demirtzoglou |
| Correspondent | Dimitris Demirtzoglou ROCHE DIAGNOSTICS CORP. 9115 HAGUE RD. Indianapolis, IN 46250 -0457 |
| Product Code | LFR |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-06-15 |
| Decision Date | 2005-09-02 |
| Summary: | summary |