510(k) K042676 ยท DHA System, Test, Human Chorionic Gonadotropin
NICHOLS ADVANTAGE HYPERGLYCOSYLATED HUMAN CHORIONIC GONADOTROPIN (H-HCG) ASSAY
| Applicant | Nichols Institute Diagnostics, San Clemente CA, US |
| Decision | Substantially Equivalent, Dec 17, 2004 |
| Received | Sep 29, 2004 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K042676
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 6, 2005 | Nichols Institute Diagnostics Hyperglycosylated Human Chorionic Gonadotropin (H-hCG) Assay Cartridges (Catalog#62-7039) Terminated |
DHA | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.