510(k) K970985 ยท JFM Enzymatic Method, Bilirubin
WAKO TOTAL BILIRUBIN V
| Applicant | Wako Chemicals USA, Inc., Richmond VA, US |
| Decision | Substantially Equivalent, Apr 21, 1997 |
| Received | Mar 18, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K970985
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.