510(k) K970877 ยท DHX System, Test, Carcinoembryonic Antigen
IMMULITE CEA
| Applicant | Diagnostic Products Corp., Los Angeles CA, US |
| Decision | Substantially Equivalent, Sep 22, 1997 |
| Received | Mar 10, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K970877
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 4, 2018 | Siemens Healthcare Diagnostics, Inc. IMMULITE /IMMULITE 1000 CEA Terminated |
DHX | None listed |
| Jul 16, 2005 | Diagnostic Products Corp Immulite/ Immulite 1000 Carcinoembryonic Antigen (CEA) LKCE1 lot 302 and 303 Terminated |
DHX | None listed |
| Jul 20, 2004 | Diagnostic Products Corp Immulite 1000 CEA
Catalog No. LKCE1 Terminated |
DHX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.