510(k) K052407 ยท JZO System, Test, Thyroid Autoantibody
ARCHITECT ANTI-TPO IMMUNOASSAY, CALIBRATORS & CONTROLS
| Applicant | Fisher Diagnostics, Middletown VA, US |
| Decision | Substantially Equivalent, Jul 18, 2006 |
| Received | Sep 1, 2005 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K052407
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 27, 2025 | Mckesson Medical-Surgical Inc. Corporate Office ABBOTT DIAGNOSTICS ARC ANTI-TPO ASSAY 100TST B REAGENT. Open, Classified |
JZO | None listed |
| Jun 8, 2023 | Abbott Ireland Limited Alinity i Anti-TPO Reagent Kit, List Number 09P3521 Open, Classified |
JZO | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.