510(k) K171482 ยท PIG Acute Kidney Injury Test System
NEPHROCHECK Test System
| Applicant | Astute Medical, Inc., San Diego CA, US |
| Decision | Substantially Equivalent, Nov 16, 2017 |
| Received | May 19, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K171482
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.