510(k) K113704 ยท LOL Hepatitis A Test (Antibody And Igm Antibody)
ARCHITECT HAVAB-G
| Applicant | Abbott Laboratories, Abbott Park IL, US |
| Decision | Substantially Equivalent, Jun 28, 2012 |
| Received | Dec 16, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K113704
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 9, 2020 | Abbott Gmbh & Co. KG ARCHITECT HAVAB G Reagent Kit. List Number 6L27 25. Terminated |
LOL | None listed |
| Nov 26, 2019 | Abbott Gmbh & Co. KG ARCHITECT HAVAB-G Calibrator, REF 6L27-01 Terminated |
LOL | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.