510(k) K980907 ยท LPS Urinary Homocystine (Nonquantitative) Test System
AXIS HOMOCYSTEINE ENZYME IMMUNOASSAY
| Applicant | Axis Biochemicals, Asa, San Diego CA, US |
| Decision | Substantially Equivalent, Oct 16, 1998 |
| Received | Mar 10, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K980907
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.