510(k) K950072 ยท JJX Single (Specified) Analyte Controls (Assayed And Unassayed)
IMMULITE(R) TBG
| Applicant | Diagnostic Products Corp., Los Angeles CA, US |
| Decision | Substantially Equivalent, Apr 3, 1995 |
| Received | Jan 9, 1995 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K950072
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 19, 2015 | Siemens Healthcare Diagnostics, Inc. IMMULITE/IMMULITE 1000 Systems TBG, catalog LKTB1
Quantitative measurement of Thyroxine-Binding Globulin (TBG) in serum, as an aid in the diagnosis and treatment of thyroid diseases. Terminated |
CEE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.