The following data is part of a premarket notification filed by Roche Diagnostics Operations (rdo) with the FDA for Alp Ifcc Gen.2.
| Device ID | K171080 |
| 510k Number | K171080 |
| Device Name: | ALP IFCC Gen.2 |
| Classification | Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes |
| Applicant | Roche Diagnostics Operations (RDO) 9115 Hague Road Indianapolis, IN 46250 |
| Contact | Patrick Stimart |
| Correspondent | Patrick Stimart Roche Diagnostics Operations (RDO) 9115 Hague Road Indianapolis, IN 46250 |
| Product Code | CJE |
| CFR Regulation Number | 862.1050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-04-11 |
| Decision Date | 2017-05-10 |
| Summary: | summary |