510(k) K993928 ยท DEW Igg, Antigen, Antiserum, Control
WAKO-IGG II-HA, IMMUNOGLOBULIN CALIBRATOR SET, IMMUNOLOBULIN STANDARD
| Applicant | Wako Chemicals USA, Inc., Richmond VA, US |
| Decision | Substantially Equivalent, Jan 18, 2000 |
| Received | Nov 18, 1999 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K993928
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.