The following data is part of a premarket notification filed by Sentinel Ch. Srl with the FDA for Sentinel Ammonia Ultra Diagnostic Assay.
| Device ID | K051114 |
| 510k Number | K051114 |
| Device Name: | SENTINEL AMMONIA ULTRA DIAGNOSTIC ASSAY |
| Classification | Enzymatic Method, Ammonia |
| Applicant | SENTINEL CH. SRL 5 VIA PRINCIPE EUGENIO Milano, IT 20155 |
| Contact | Davide Spada |
| Correspondent | Davide Spada SENTINEL CH. SRL 5 VIA PRINCIPE EUGENIO Milano, IT 20155 |
| Product Code | JIF |
| CFR Regulation Number | 862.1065 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-05-02 |
| Decision Date | 2005-11-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08058056680181 | K051114 | 000 |