510(k) DEN180014 ยท QFA Assay For Detection Of Proteases In Chronic Wounds
WOUNDCHEK Bacterial Status
| Applicant | Alere Scarborough, Inc., Scarborough ME, US |
| Decision | Unknown, Dec 2, 2019 |
| Received | Mar 23, 2018 |
| Type | Direct |
| FDA record | Open on fda.gov |
Recalls that name DEN180014
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.