LiverSmart
Liver Iron Concentration Imaging Companion Diagnostic For Deferasirox
Resonance Health Analysis Services Pty Ltd
The following data is part of a premarket notification filed by Resonance Health Analysis Services Pty Ltd with the FDA for Liversmart.
Pre-market Notification Details
| Device ID | K213776 |
| 510k Number | K213776 |
| Device Name: | LiverSmart |
| Classification | Liver Iron Concentration Imaging Companion Diagnostic For Deferasirox |
| Applicant | Resonance Health Analysis Services Pty Ltd 141 Burswood Road Perth, AU 6100 |
| Contact | Mitchell Wells |
| Correspondent | Mitchell Wells Resonance Health Analysis Services Pty Ltd 141 Burswood Road Perth, AU 6100 |
| Product Code | PCS |
| CFR Regulation Number | 892.1001 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-12-02 |
| Decision Date | 2021-12-29 |
Trademark Results [LiverSmart]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 LIVERSMART 86509717 4803520 Live/Registered |
NATURENETICS, INC. 2015-01-21 |
 LIVERSMART 79328449 not registered Live/Pending |
Resonance Health Analysis Services Pty Ltd 2021-10-13 |
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