510(k) K022335 ยท MQL Media, Reproductive
ALLGRAD AND ALLGRAD100
| Applicant | <Genx> Intl., Inc., Guilford CT, US |
| Decision | Substantially Equivalent, Aug 23, 2002 |
| Received | Jul 18, 2002 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K022335
| 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 |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.