510(k) K840211 ยท KQJ System, Fibrinogen Determination
FIBRI-PREST AUTOMATE HA34
| Applicant | Wellcome Diagnostics, Walker MI, US |
| Decision | Substantially Equivalent, Mar 2, 1984 |
| Received | Jan 19, 1984 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K840211
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 28, 2025 | Diagnostica Stago, Inc. STA - Fibrinogen 5. Model/Catalog Number: 00674.
The STA - Fibrinogen 5 kit is intended for use with the analyzers of the STA-R, STA Compact and STA Satellite families for the quantitative determina Open, Classified |
KQJ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.