510(k) K100200 ยท LDP Colorimetry, Acetaminophen
ADVIA CHEMISTRY ACETAMINOPHEN REAGENT, MODEL REF 07989138
| Applicant | Siemens Healthcare Diagnostics, Tarrytown NY, US |
| Decision | Substantially Equivalent, Aug 2, 2010 |
| Received | Jan 25, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K100200
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 19, 2015 | Siemens Healthcare Diagnostics, Inc. ADVIA Chemistry Acetaminophen reagents; for in vitro diagnostic use in the quantitative determination of acetaminophen in human serum and plasma (lithium heparin) on ADVIA Chemistry systems. Terminated |
LDP | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.