The following data is part of a premarket notification filed by Roche Diagnostics Corp. with the FDA for Accu-chek Ultrflex Infusion Set.
| Device ID | K101196 |
| 510k Number | K101196 |
| Device Name: | ACCU-CHEK ULTRFLEX INFUSION SET |
| Classification | Set, Administration, Intravascular |
| 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 | FPA |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-04-29 |
| Decision Date | 2010-08-27 |
| Summary: | summary |