510(k) K022355 ยท DIO Enzyme Immunoassay, Cocaine And Cocaine Metabolites
QUICKTOX MULTIPLE DRUG DIPCARD COC/MET/THC/AMP/PCP/BZO/BAR/MTD/TCA, MODEL QT61
| Applicant | Branan Medical Corp., Irvine CA, US |
| Decision | Substantially Equivalent, Jul 30, 2002 |
| Received | Jul 19, 2002 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K022355
| 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 |
| Dec 17, 2019 | Ameditech Inc QuickTox 5 Panel Drug Screen DipCard Terminated |
DJG | None listed |
| Dec 15, 2017 | Ameditech Inc Alere iScreen Dx Urine Drug Screen Card Terminated |
LFH | None listed |
| Jun 26, 2017 | Ameditech Inc Alere iScreen Dx Urine Drug Screen Card, 20 Drug Detection, Kit Contents include 26 individually pouched devices and 1 IFU insert.
The Alere iScreen Dx Drug Screen Card is a rapid urine screening te Terminated |
LFH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.