510(k) K931703 ยท JHR Radioimmunoassay, Immunoglobulins (D, E)
IMMULITE TOTAL IGE
| Applicant | Diagnostic Products Corp., Los Angeles CA, US |
| Decision | Substantially Equivalent, Aug 16, 1993 |
| Received | Apr 6, 1993 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K931703
| 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 |
| Apr 25, 2014 | Siemens Healthcare Diagnostics IMMULITE 2000 /IMMULITE 2000 XPi Systems TIE Total IgE, REF L2KIE2, SMN 10380873, and L2KIE6, SMN 10380872, IVD --- Siemens Healthcare Diagnostics Products Ltd.
For in vitro diagnostic use with the I Terminated |
JHR | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.