510(k) K932926 ยท CHP Radioimmunoassay, Estradiol
IMMULITE ESTRADIOL
| Applicant | Diagnostic Products Corp., Los Angeles CA, US |
| Decision | Substantially Equivalent, Jan 10, 1994 |
| Received | Jun 15, 1993 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K932926
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 13, 2016 | Siemens Healthcare Diagnostics, Inc IMMULITE 1000 Estradiol
Test Code E2
Catalog Number: LKE21, LKE21(D), LKE25
SMN: 10381132, 10702832, 10381142
Product Usage:
For in vitro diagnostic use with the IMMULITE and IMMULITE 1000 Analyzers Terminated |
CHP | None listed |
| Jan 13, 2016 | Siemens Healthcare Diagnostics, Inc IMMULITE 2000 EstradiolTest Code E2
Catalog Number: L2KE22, L2KE22 (D), L2KE26, L2KE26 (D)
SMN: 10381178, 10702833, 10381177, 10702834
Product Usage:
For in vitro diagnostic use the IMMULITE2000 syst Terminated |
CHP | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.