510(k) K052308 ยท JZO System, Test, Thyroid Autoantibody
ARCHITECT ANTI-TG IMMUNOASSAY REAGENTS, CALIBRATORS, CONTROLS AND SYSTEM ASSAY CD-ROM
| Applicant | Fisher Diagnostics, Middletown VA, US |
| Decision | Substantially Equivalent, May 10, 2006 |
| Received | Aug 24, 2005 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K052308
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.