510(k) K082503 ยท DFH Kappa, Antigen, Antiserum, Control
DIMENSION VISTA LG LIGHT CHAINS, TYPE KAPPA, DIMENSION VISTA LG LIGHT CHAINS, TYPE LAMBDA, DIMENSION VISTA PROTEIN 1 CAL
| Applicant | Siemens Healthcare Diagnostics, Newark DE, US |
| Decision | Substantially Equivalent, Dec 19, 2008 |
| Received | Aug 29, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K082503
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 23, 2017 | Siemens Healthcare Diagnostics, Inc. Dimension Vista Protein 1 Calibrator, PROT 1 CAL, Siemens Material Number (SMN) 10465664 (US) and 10469516 (OUS), Product Code KC710U (US) and KC710 (OUS); IVD Terminated |
CHN | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.