510(k) K100433 ยท LKQ Antibody Igm,If, Cytomegalovirus Virus
IMMULITE 2000 CMV IGM, IMMULITE CMV IGM CONTROLS, AND IMMULITE 200 CMV IGM ADJUSTOR MODEL L2KCM2, L2KCM6, LCMC1, LCMC2,
| Applicant | Siemens Healthcare Diagnostics, West Sacramento CA, US |
| Decision | Substantially Equivalent, May 13, 2010 |
| Received | Feb 16, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K100433
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 30, 2016 | Siemens Healthcare Diagnostics, Inc. IMMULITE/ IMMULITE 1000 Systems CMM CMV IgM Assay, REF/Catalog Number LKCM1(D) - 100 tests (US), Siemens Material Number (SMN) 10370301 (US), Unique Device Identification Number (UDI) 00630414985718 ( Terminated |
LKQ | None listed |
| Aug 30, 2016 | Siemens Healthcare Diagnostics, Inc. IMMULITE 2000/IMMULITE 2000XPi Systems CMM CMV IgM Assay, REF/Catalog Number L2KCM2(D) - 200 tests (US), SMN 10370302 (US), UDI 00630414985725 (US); and REF/Catalog Number L2KCM2 - 200 tests (OUS), S Terminated |
LKQ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.