510(k) K001004 ยท JIS Calibrator, Primary
WAKO APOLIPOPROTEIN HIGH LEVEL CALIBRATOR
| Applicant | Wako Chemicals USA, Inc., Richmond VA, US |
| Decision | Substantially Equivalent, Jun 1, 2000 |
| Received | Mar 29, 2000 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K001004
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.