510(k) K053175 ยท DKZ Enzyme Immunoassay, Amphetamine
AMEDITECH DRUGSMARTCUP
| Applicant | Ameditech, Inc., San Diego CA, US |
| Decision | Substantially Equivalent, Dec 8, 2005 |
| Received | Nov 14, 2005 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K053175
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 31, 2011 | Express Diagnostics Int'l., Inc. Drug Check, Distributed by Express Diagnostics Intl Inc., 1550 Industrial Drive, Blue Earth, MN 56013.
Following Cup and Dip product models involved in the recall:
40900
40901
30500-A
30575 -A
3060 Terminated |
DIC | None listed |
| May 27, 2011 | Express Diagnostics Int'l., Inc. DrugCheck, Manufactured by: Express Diagnostics Int;l Inc. 1550 Industrial Drive, Blue Earth MN 56013 USA, Model numbers :
70801-4(NxScan OnSite, AMP500-COC-MDMA-MET500-MTD-OP1300-TCH-BUP-pH,SG-NI,CR Terminated |
DJG | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.