510(k) K122633 ยท LDJ Enzyme Immunoassay, Cannabinoids
TOXCUP DRUG SCREEN CUP
| Applicant | Branan Medical Corp., Irvine CA, US |
| Decision | Substantially Equivalent, Feb 7, 2013 |
| Received | Aug 29, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K122633
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 18, 2020 | Ameditech Inc Alere iCup Drug Detection (AMT Item Number/ AMT Description):
I-DXA-10/ "Alere" iCup Dx 10 Drug Detection + Adulteration AMP/BAR/BZO/COC/MET/MDMA/MTD/MOP/OXY/THC
Bl, Cr, Ni, pH, SG",
I-DXA-13B/"Aler Terminated |
DIO | None listed |
| Aug 18, 2020 | Ameditech Inc CLIA Waived Rapid Drug Test (AMT Item Number/ AMT Description):
X07-CLIA-SDDT-25 / CLIA Waived" Inc. Single Drug Dipstick Test
BUP10,
X07-CLIA-SDDT-25 / "CLIA Waived" Inc. Single Drug Dipstick Test Terminated |
LDJ | None listed |
| Aug 18, 2020 | Ameditech Inc Consult Diagnostics Drugs Abuse Test Cup (AMT Item Number/ AMT Description):
164-DXA14 /"Consult Diagnostics
DRUGS OF ABUSE TEST CUP 14-DRUG PANEL WITH ADULTERANTS
AMP500/BAR/BUPG/BZO/COC150/MDMA/MET Terminated |
LDJ | None listed |
| Aug 18, 2020 | Ameditech Inc Henry Schein One Step + DOA Cup (AMT Item Number/ AMT Description):
570-1066 / "Henry Schein OneStep+ DOA Cup 14 Panel
AMP500/BAR/BUPG/BZO/COC150/MDMA/MET500/MOP/MTD/OXY/PCP/PPX/TCA/THC (Bl, Cr, Ni, Terminated |
LDJ | None listed |
| Aug 18, 2020 | Ameditech Inc Noble 1 Step+ Cup (AMT Item Number/ AMT Description):
NBCA-13A-B /"Noble 1 Step + Cup"
THC50/COC150; OPI300/MET500; AMP500/BZO300;
BAR300/MTD300; BUPG10/TCA1000; MDMA500/OXY100;
w/ Cr, Ni, pH, Bl, Terminated |
LDJ | None listed |
| Aug 18, 2020 | Ameditech Inc iCup Dx14 Drug Screen Cup(AMT Item Number/ AMT Description):
X11-I-DXA-2147-011/ "iCup" Dx 14 Drug Screen Cup
14 Drug Detection: (THC50/COC150)+(MOP300/MET500)+(AMP500/BZO300)+
(BAR300/MTD300)+(BUPG1 Terminated |
LDJ | None listed |
| Aug 18, 2020 | Ameditech Inc ToxCup Drug Screen Cup (AMT Item Number/ AMT Description):
HT29A/"ToxCup Drug Screen Cup
COC300/MET500/OPI300/THC50/AMP1000/PCP25/OXY100
Adulteration Screen for CR - NI - PH - BL - S.G.",
DT14/ "T Terminated |
DIO | None listed |
| Aug 18, 2020 | Ameditech Inc First Check 14 Panel Drug Cup: (BMC style); AMT Item Number 990700B Terminated |
LDJ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.