The following data is part of a premarket notification filed by Roche Diagnostics Corp. with the FDA for Super Sani-cloth/ Accu-chek Inform Ii System.
| Device ID | K130138 |
| 510k Number | K130138 |
| Device Name: | SUPER SANI-CLOTH/ ACCU-CHEK INFORM II SYSTEM |
| Classification | System, Test, Blood Glucose, Over The Counter |
| Applicant | ROCHE DIAGNOSTICS CORP. 9115 HAGUE RD. Indianapolis, IN 46250 |
| Contact | Justin Davis |
| Correspondent | Justin Davis ROCHE DIAGNOSTICS CORP. 9115 HAGUE RD. Indianapolis, IN 46250 |
| Product Code | NBW |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-01-18 |
| Decision Date | 2013-03-15 |
| Summary: | summary |