510(k) K060791 ยท DJR Enzyme Immunoassay, Methadone
TRIAGE TOX DRUG SCREEN, MODEL 94400
| Applicant | Biosite Incorporated, San Diego CA, US |
| Decision | Substantially Equivalent, Jun 22, 2006 |
| Received | Mar 23, 2006 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K060791
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 17, 2014 | Alere San Diego, Inc. Product Brand Name(s): Alere Triage TOX+MTD Drug Screen, Catalog Number 94400, Lots W56013B and W56035B.
25 individually pouched devices in a labeled kit box.
Indications for use: The Alere Triage T Terminated |
DJR | None listed |
| Oct 10, 2012 | Alere San Diego, Inc. Triage TOX Drug Screen Panel, Model# 94400.
Product Usage:
The Triage TOX Drug Screen is a fluorescence immunoassay intended to be used with the Triage Meters for the point-of-care qualitative dete Terminated |
DJR | None listed |
| 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 |
| Jul 19, 2012 | Alere San Diego, Inc. Alere Triage Tox+MTD Drug Screen, PN 94400
Product Usage:
The Alere Triage TOX Drug Screen is a fluorescence immunoassay to be used with the Alere Triage Meters for the qualitative determination of t Terminated |
DJR | None listed |
| Apr 20, 2012 | Alere San Diego dba Biosite Innovacon Hemosense Inc Triage TOX Drug Screen (MTD) Panel, Model # 94400.
Type of Packaging: 25 individually pouched devices in a labeled kit box.
The Triage TOX Drug Screen is a fluorescence immunoassay intended to be use Terminated |
DJR | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.