510(k) K980855 ยท DHX System, Test, Carcinoembryonic Antigen
IMMULITE 2000 CARCINOEMBRYONIC ANTIGEN (CEA) KIT
| Applicant | Dpc Cirrus, Randolph NJ, US |
| Decision | Substantially Equivalent, Apr 21, 1998 |
| Received | Mar 5, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K980855
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 4, 2018 | Siemens Healthcare Diagnostics, Inc. IMMULITE 2000/IMMULITE 2000 XPi CEA Terminated |
DHX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.