510(k) K032057 ยท DIO Enzyme Immunoassay, Cocaine And Cocaine Metabolites
TOXCUP DRUG SCREEN CUP AMP/COC/MET/OPI/PCP/THC
| Applicant | Branan Medical Corp., Irvine CA, US |
| Decision | Substantially Equivalent, Aug 21, 2003 |
| Received | Jul 2, 2003 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K032057
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| 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 |
| Apr 24, 2014 | Branan Medical Corporation ToxCup Drug Screen Cup, Catalogue Numbers: HT15, HT15A, PT11, PT11A, PT15A, PT23A, a screening device for the detection of drugs and drug metabolites in human urine. For in vitro diagnostic use only. Terminated |
DIO | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.