510(k) K043242 ยท LDP Colorimetry, Acetaminophen
TRIAGE TOX DRUG SCREEN
| Applicant | Biosite Incorporated, San Diego CA, US |
| Decision | Substantially Equivalent, Feb 28, 2005 |
| Received | Nov 23, 2004 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K043242
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 26, 2012 | Alere San Diego, Inc. Alere Triage TOX Drug Screen 9 Panel, P/N: 94402.
The Alere Triage TOX Drug Screen is a fluorescence immunoassay intended to be used with the Alere Triage Meters for the qualitative determination of Terminated |
LDP | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.