510(k) K013566 ยท CEW Radioimmunoassay, Parathyroid Hormone
IMMULITE INTACT PTH, IMMULITE 2000 INTACT PTH, MODELS LKPP1 (100 TESTS), LKPP5 (500 TESTS), L2KPP2 (200 TESTS), L2KPP6
| Applicant | Diagnostic Products Corp., Los Angeles CA, US |
| Decision | Substantially Equivalent, Nov 20, 2001 |
| Received | Oct 26, 2001 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K013566
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 27, 2025 | Siemens Healthcare Diagnostics, Inc. Assay: IMMULITE 2000 Intact PTH;
Test Code: iPT;
Siemens Material Number (SMN): (1) 10381441, (2) 10381442;
Catalog Number: (1) L2KPP2, (2) L2KPP6; Open, Classified |
CEW | None listed |
| Nov 22, 2016 | Siemens Healthcare Diagnostics, Inc. SIEMENS IMMULITE 2000/2000 Xpi Systems Intact PTH (Parathyroid Hormone)
Test Code iPTH, REF/Catalog Number L2KPP2, Siemens Material Number (SMN) 10381441 and REF/Catalog Number L2KPP6, SMN 10381442; Terminated |
CEW | None listed |
| Jul 20, 2004 | Diagnostic Products Corp IMMULITE 2000 Intact PTH kit Terminated |
CEW | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.