510(k) K854079 ยท GHM Test, Sickle Cell
THROMBO SCREEN SICKLE CELL ASSAY SET
| Applicant | Pacific Hemostasis, Ventura CA, US |
| Decision | Substantially Equivalent, Oct 31, 1985 |
| Received | Oct 7, 1985 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K854079
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 30, 2004 | Fisher Diagnostic, A Company of Fisher Scientific LLC Pacific Hemostasis brand SickleScreen Sickling Hemoglobin Screening Kit, Fisher Diagnostics catalog number 100250, containing reagents for 30 determinations. Terminated |
GHM | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.