510(k) K001651 ยท JJX Single (Specified) Analyte Controls (Assayed And Unassayed)
BIO-RAD %CDT TIA
| Applicant | Axis-Shield Biochemicals, Asa, San Diego CA, US |
| Decision | Substantially Equivalent, Nov 22, 2000 |
| Received | May 30, 2000 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K001651
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.