510(k) K000121 ยท DFC Lipoprotein, Low-Density, Antigen, Antiserum, Control
IMMAGE IMMUNOCHEMISTRY SYSTEM LIPOPROTEIN(A) LPAX REAGENT, ARRAY SYSTEM LIPOPROTEIN(A) LPA REAGENT, LIPOPROTEIN(A) CALIB
| Applicant | Beckman Coulter, Inc., Brea CA, US |
| Decision | Substantially Equivalent, May 17, 2000 |
| Received | Jan 18, 2000 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K000121
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.