510(k) K110726 ยท LDP Colorimetry, Acetaminophen
ROCHE ACETAMINOPHEN ASSAY
| Applicant | Roche Diagnostics, Indianapolis IN, US |
| Decision | Substantially Equivalent, Dec 23, 2011 |
| Received | Mar 16, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K110726
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 2, 2018 | Roche Diagnostics Corporation Roche Acetaminophen assay
03255379160-HAcetaminophen (P)
20767174160- cobas c Integra AAcetaminophen150 test Terminated |
LDP | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.