510(k) K830976 ยท JIN Nitroprusside, Ketones (Urinary, Non-Quant.)
HELENA BIOSTRIP K
| Applicant | Helena Laboratories, Mchenry IL, US |
| Decision | Substantially Equivalent, May 4, 1983 |
| Received | Mar 29, 1983 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K830976
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.