510(k) K963847 ยท JIS Calibrator, Primary
WAKO DIRECT HDL-C
| Applicant | Wako Chemicals USA, Inc., Richmond VA, US |
| Decision | Substantially Equivalent, Dec 24, 1996 |
| Received | Sep 25, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K963847
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.