510(k) K042448 ยท JJX Single (Specified) Analyte Controls (Assayed And Unassayed)
DIAZYME HOMOCYSTEINE ENZYMATIC ASSAY KIT
| Applicant | General Atomics, San Diego CA, US |
| Decision | Substantially Equivalent, Oct 29, 2004 |
| Received | Sep 9, 2004 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K042448
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.