The following data is part of a premarket notification filed by Roche Diagnostics Operations (rdo) with the FDA for Ammonia Ii.
| Device ID | K183517 |
| 510k Number | K183517 |
| Device Name: | Ammonia II |
| Classification | Enzymatic Method, Ammonia |
| Applicant | Roche Diagnostics Operations (RDO) 9115 Hague Road Indianapolis, IN 46250 |
| Contact | Noel B. Mencias |
| Correspondent | Noel B. Mencias Roche Diagnostics Operations (RDO) 9115 Hague Road Indianapolis, IN 46250 |
| Product Code | JIF |
| CFR Regulation Number | 862.1065 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-12-18 |
| Decision Date | 2019-02-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04015630936526 | K183517 | 000 |
| 04015630936533 | K183517 | 000 |
| 07613336121429 | K183517 | 000 |