510(k) K012077 ยท LFX Enzyme Linked Immunoabsorbent Assay, Rubella
IMMULITE RUBELLA IGM,LKRM1, LKRM2, IMMULITE 2000 RUBELLA IGM, MODEL L2KRM2, L2KRM6
| Applicant | Diagnostic Products Corp., Los Angeles CA, US |
| Decision | Substantially Equivalent, Jan 10, 2002 |
| Received | Jul 2, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K012077
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 24, 2016 | Siemens Healthcare Diagnostics, Inc. SIEMENS IMMULITE/IMMULITE 1000 Systems Rubella IgM (RUM), REF/Catalog Number LKRM1 (OUS), Siemens Material Number (SMN) 10381282 (OUS), Unique Device Identification Number (UDI) 00630414964577; IVD -- Terminated |
LFX | None listed |
| Aug 24, 2016 | Siemens Healthcare Diagnostics, Inc. SIEMENS IMMULITE/IMMULITE 2000 Systems Rubella IgM (RUM), REF/Catalog Number for US: L2KRM2(D), Siemens Material Number (SMN) for US: 10374021, REF/Catalog # for OUS: L2KRM2, SMN for OUS: 10381327; Un Terminated |
LFX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.