510(k) K003597 ยท LPS Urinary Homocystine (Nonquantitative) Test System
IMMULITE HOMOCYSTEINE MODEL LKHO1 / IMMULITE 2000 HOMOCYSTEINE MODEL L2KHO2
| Applicant | Diagnostic Products Corp., Los Angeles CA, US |
| Decision | Substantially Equivalent, Feb 5, 2001 |
| Received | Nov 21, 2000 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K003597
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.