510(k) K950088 ยท JZO System, Test, Thyroid Autoantibody
ORGENTEC ANTI-TG/ANTI-TPO PIA (PIN IMMUNO ASSAY)
| Applicant | American Laboratory Products Co., Ltd., Windham NH, US |
| Decision | Substantially Equivalent, Apr 21, 1995 |
| Received | Jan 10, 1995 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K950088
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.