510(k) K082898 ยท NGL Test, Opiates, Over The Counter
AMEDICA DRUG SCREEN TEST CUP
| Applicant | Amedica Biotech, Inc., Hayward CA, US |
| Decision | Substantially Equivalent, Dec 19, 2008 |
| Received | Sep 30, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K082898
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 30, 2017 | Ameditech Inc Accutest Drug Test Cup 5+3
Product Usage:
The Accutest Drug Test Cup is an in vitro diagnostic test for the rapid detection of multiple drugs in human urine. The test is intended as the first step in Terminated |
NGG | None listed |
| Jul 5, 2016 | Branan Medical Corporation AmediCheck Instant Test Cup, Part No. C-C0501A-3A
Product Usage:
The AmediCheck Instant Test Cup is an in vitro diagnostic test for the rapid detection of the following drugs in human urine. Drug Ana Terminated |
DIO | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.