510(k) K820594 ยท JIL Method, Enzymatic, Glucose (Urinary, Non-Quantitative)
BIOSTRIP G
| Applicant | Helena Laboratories, Walker MI, US |
| Decision | Substantially Equivalent, May 5, 1982 |
| Received | Mar 4, 1982 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K820594
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.