510(k) K030113 ยท DJG Enzyme Immunoassay, Opiates
MONITECT OXYCODONE DRUG SCREEN CASSETTE TEST, MODEL MC 23, FASTECT OXYCODONE DRUG SCREEN DIPSTICK TEST, MODEL MD23
| Applicant | Branan Medical Corp., Irvine CA, US |
| Decision | Substantially Equivalent, Jul 2, 2003 |
| Received | Jan 13, 2003 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K030113
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 18, 2020 | Ameditech Inc Fastect II Drug Screen Dipstick Test Single Drug Detection (AMT Item Number/ AMT Description):
MF25/ "Fastect II Drug Screen Dipstick Test Single Drug Detection: BUP10", QF09/"Fastect II Drug Screen Terminated |
DIO | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.