510(k) K001933 ยท DFC Lipoprotein, Low-Density, Antigen, Antiserum, Control
WAKO AUTOKIT LP(A) & LP(A) CALIBRATOR/COBAS BIO
| Applicant | Wako Chemicals USA, Inc., Richmond VA, US |
| Decision | Substantially Equivalent, Jul 24, 2000 |
| Received | Jun 26, 2000 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K001933
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.