510(k) K013757 ยท LDP Colorimetry, Acetaminophen
ROCHE ACETAMINOPHEN
| Applicant | Roche Diagnostics Corp., Indianapolis IN, US |
| Decision | Substantially Equivalent, Jan 8, 2002 |
| Received | Nov 13, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K013757
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 16, 2011 | Roche Diagnostics Operations, Inc. Acetaminophen Test System for use on the Roche/Hitachi, part number 03255379190, Roche Diagnostics Corporation, Indianapolis, IN.
For the quantitative determinations of toxic levels of acetaminoph Terminated |
LDP | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.