510(k) K152061 ยท JZO System, Test, Thyroid Autoantibody
IMMULITE 2000 TSI Assay, IMMULITE 2000 TSI Calibration Verification Material
| Applicant | Siemens Healthcare Diagnostics, Inc., Tarrytown NY, US |
| Decision | Substantially Equivalent, Mar 3, 2016 |
| Received | Jul 24, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K152061
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 27, 2022 | Siemens Healthcare Diagnostics, Inc. IMMULITE 2000 and IMMULITE 2000 XPi Thyroid Stimulating Immunoglobulins (TSI)
Siemens Material Number (SMN): 10876421 US; 10713448 (OUS) Open, Classified |
JZO | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.