510(k) K973784 ยท DKZ Enzyme Immunoassay, Amphetamine
TRIAGE PANEL FOR DRUGS OF ABUSE, PLUS TRICYCLIC ANTIDEPRESSANTS AND OTHER TRIAGE DRUG TESTS
| Applicant | Biosite Incorporated, San Diego CA, US |
| Decision | Substantially Equivalent, Dec 3, 1997 |
| Received | Oct 3, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K973784
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 14, 2017 | Alere San Diego, Inc. Triage Drugs of Abuse Plus TCA 25 Test Kit, Model Numbers 92000, 92590, 92591; 25 individually pouched devices, 1 bottle of
Wash Solution, 1 Pipette and 50 Pipette Tips in a labeled kit box.
Product Completed |
DKZ | None listed |
| Mar 1, 2012 | Alere San Diego Product Brand Names: Triage Drugs of Abuse Panel 8 Test Kit (K924476), Triage Drugs of Abuse
Panel Plus TCA (K973784), & Triage Drugs of Abuse Panel Plus PPX (K014247)
Model Number: 90008, 92002, & 92 Terminated |
DIS | None listed |
| Jan 11, 2012 | Alere San Diego Triage Drugs of Abuse Panel Plus TCA 25 Test Kit, PN (Model Number) 92000
An immunoassay used for the qualitative determination of the presence of the major metabolites of drugs of abuse and Tricycli Terminated |
DKZ | None listed |
| Mar 17, 2009 | Biosite Inc Triage Drugs of Abuse Panel, Model Number: 95000.
Is an immunoassay test kit used for the qualitative determination of the presence of the major metabolites of drugs of abuse in urine. Terminated |
DKZ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.