510(k) K102699 ยท LCD Enzyme Immunoassay, Gentamicin
ARCHITECT IGENTAMICIN REAGENTS; ARCHITECT IGENTAMICIN CALIBRATORS
| Applicant | Abbott Laboratories, Abbott Park IL, US |
| Decision | Substantially Equivalent, Apr 1, 2011 |
| Received | Sep 20, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K102699
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 12, 2020 | Abbott Gmbh & Co. KG ARCHITECT iGentamicin Reagent Kit - Product Usage: The measurements obtained are used in the diagnosis and treatment of gentamicin overdose and in monitoring levels of gentamicin to help ensure approp Open, Classified |
LCD | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.