510(k) K880495 ยท JJW Urinalysis Controls (Assayed And Unassayed)
LYPHOCHEK QUANTITATIVE URINE CONTROL ABNORMAL (2)
| Applicant | Bio-Rad, Hercules CA, US |
| Decision | Substantially Equivalent, Mar 15, 1988 |
| Received | Feb 4, 1988 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K880495
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.