510(k) K872426 ยท DBA Complement C1 Inhibitor (Inactivator), Antigen, Antiserum, Control
CYTOTECH C1-INHIBITOR ENZYME IMMUNOASSAY
| Applicant | Cytotech, Inc., San Diego CA, US |
| Decision | Substantially Equivalent, Jul 23, 1987 |
| Received | Jun 22, 1987 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K872426
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 30, 2023 | Quidel Corporation MicroVue C1-Inhibitor Plus EIA for measuring the amount of functional C1-lnhibitor protein in human plasma or serum, Catalog Number A037, Containing Coated Strips, REF: 4634, with an ID number of 2200 Open, Classified |
DBA | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.