510(k) K153165 ยท PIG Acute Kidney Injury Test System
NEPHROCHECK Test Kit, ASTUTE140 Meter, NEPHROCHECK Liquid Controls Kit, NEPHROCHECK Calibration Verification (Cal Vers) Kit
| Applicant | Astute Medical, Inc., San Diego CA, US |
| Decision | Substantially Equivalent, Jun 1, 2016 |
| Received | Nov 2, 2015 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K153165
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.