510(k) K960067 ยท JHR Radioimmunoassay, Immunoglobulins (D, E)
IMMILITE TOTAL IGE
| Applicant | Diagnostic Products Corp., Los Angeles CA, US |
| Decision | Substantially Equivalent, Feb 14, 1996 |
| Received | Jan 5, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K960067
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 25, 2014 | Siemens Healthcare Diagnostics IMMULITE /IMMULITE 1000 Systems TIE Total IgE, REF LKIE1, SMN 10380867, IVD --- Siemens Healthcare Diagnostics Products Ltd. For in vitro diagnostic use with the IMMULITE, IMMULITE 1000, and IMMULITE Terminated |
JHR | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.