510(k) K980812 ยท DFC Lipoprotein, Low-Density, Antigen, Antiserum, Control
IMX HOMOCYSTEINE
| Applicant | Axis Biochemicals, Asa, San Diego CA, US |
| Decision | Substantially Equivalent, Oct 1, 1998 |
| Received | Mar 3, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K980812
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.