510(k) K133122 ยท JJX Single (Specified) Analyte Controls (Assayed And Unassayed)
IMMULITE 2000; 3GALLERGY SPECIFIC IGE CONTROL VERIFICATION MATERIAL (CVM), TOTAL IGE CONTROL VERIFICATION MATERIAL (CVM)
| Applicant | Siemens Healthcare Diagnostics, Inc., Tarrytown NY, US |
| Decision | Substantially Equivalent, Oct 30, 2013 |
| Received | Sep 30, 2013 |
| Type | Abbreviated |
| FDA record | Open on fda.gov |
Recalls that name K133122
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.