510(k) K082508 ยท DJG Enzyme Immunoassay, Opiates
FASTECT II BUP DRUG SCREEN DIPSTICK AND QUICKTOX BUP DRUG SCREEN DIPCARD
| Applicant | Branan Medical Corporation, Irvine CA, US |
| Decision | Substantially Equivalent, Nov 21, 2008 |
| Received | Aug 29, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K082508
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 18, 2020 | Ameditech Inc Alere iScreen Single Drug Detection (AMT Item Number/ AMT Description):
X11-IS1 BUP-DX/ "Alere iScreen" Dx Single Dip Card Single Drug Detection: Buprenorphine (BUP)",
X11-IS1 BAR-DX /"Alere iScreen" Terminated |
DIO | None listed |
| Aug 18, 2020 | Ameditech Inc Alere iScreen Multi Drug Detection (AMT Item Number/ AMT Description):
X11-IS12-DX / "Alere iScreen" Dx Multi-Drugs of Abuse Dip Test
12 Drug Detection:AMP1000+BAR300+BZO300+COC300+THC50+MTD300+MET5 Terminated |
DIO | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.