510(k) K180835 ยท LDP Colorimetry, Acetaminophen
SEKURE Acetaminophen L3K Assay
| Applicant | Sekisui Diagnostics P.E.I., Inc., Charlottetown,, CA |
| Decision | Substantially Equivalent, Feb 8, 2019 |
| Received | Mar 30, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K180835
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.