510(k) K061718 ยท DKZ Enzyme Immunoassay, Amphetamine
INNOVACON SPECTRUM II TEST CARD
| Applicant | Innovacon, Inc., San Diego CA, US |
| Decision | Substantially Equivalent, Nov 13, 2006 |
| Received | Jun 19, 2006 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K061718
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 27, 2011 | Alere San Diego Calloway LabsMulti-Drug 9 Panel Assay
A rapid, one step screening test for the simultaneous for the qualitative detection of multiple drugs and drug metabolites in human urine. Terminated |
DKZ | None listed |
| Oct 6, 2009 | Biosite Inc Multi-Drug iCup Drug Screen Test Cup. Part Number DUD-1107-012-08A.
Subsequent Product Codes: DIO, DIS, DJC, DJG, DJR, JXM, JXN, LCM, LDJ, LFG Terminated |
DKZ | None listed |
| Oct 6, 2009 | Biosite Inc Multi-Drug 8 Panel Integrated iCup Drug Screen Test Cup. Part Number DUD-187-013-08A.
Subsequent Product Codes: DIO, DIS, DJC, DJG, DJR, JXM, JXN, LCM, LDJ, LFG Terminated |
DKZ | None listed |
| Oct 6, 2009 | Biosite Inc Multi-Drug iCup Drug Screen Test Cup. Part Number DUD-197-014-08A.
Subsequent Product Codes: DIO, DIS, DJC, DJG, DJR, JXM, JXN, LCM, LDJ, LFG Terminated |
DKZ | None listed |
| Oct 6, 2009 | Biosite Inc Multi-Drug iCup Drug Screen Test Cup. Part Number DUE-1127-022-08A.
Subsequent Product Codes: DIO, DIS, DJC, DJG, DJR, JXM, JXN, LCM, LDJ, LFG Terminated |
DKZ | None listed |
| Oct 6, 2009 | Biosite Inc Multi-Drug 8 Panel Integrated iCup Drug Screen Test Cup. Part Number DUE-187-071-08A.
Subsequent Product Codes: DIO, DIS, DJC, DJG, DJR, JXM, JXN, LCM, LDJ, LFG Terminated |
DKZ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.