510(k) K013984 ยท MOI System, Test, Immunological, Antigen, Tumor
IMMULITE BR-MA, MODEL #LKBR; IMMULITE 2000 BR-MA, MODEL #L2KBR
| Applicant | Diagnostic Products Corp., Los Angeles CA, US |
| Decision | Substantially Equivalent, Mar 28, 2002 |
| Received | Dec 3, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K013984
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 4, 2018 | Siemens Healthcare Diagnostics, Inc. IMMULITE /IMMULITE 1000 BR-MA (CA15-3) Terminated |
MOI | None listed |
| May 4, 2018 | Siemens Healthcare Diagnostics, Inc. IMMULITE 2000/IMMULITE 2000 XPi BR-MA (CA15-3) Terminated |
MOI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.