510(k) K111822 ยท KFF Assay, Heparin
STA(R) - LIQUID ANTI-XA, MULTI HEP CALIBRATOR, QUALITY HNF / UFH, QUALITY HBPM / LMWH
| Applicant | Diagnostica Stago, Inc., Rome, IT |
| Decision | Substantially Equivalent, Oct 26, 2011 |
| Received | Jun 28, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K111822
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 28, 2025 | Diagnostica Stago, Inc. STA-Liquid Anti-Xa 4. Model/Catalog Number: 00311US.
The STA - Liquid Anti-Xa kits are intended for use with STA-R, STA Compact and STA Satellite analyzers, for the quantitative determination of the Open, Classified |
KFF | None listed |
| Aug 28, 2025 | Diagnostica Stago, Inc. STA-Liquid Anti-Xa 8. Model/Catalog Number: 00322US.
The STA - Liquid Anti-Xa kits are intended for use with STA-R, STA Compact and STA Satellite analyzers, for the quantitative determination of the Open, Classified |
KFF | None listed |
| Sep 16, 2014 | Diagnostica Stago, Inc. Stago IVD, Liquid Anti-Xa, NDC 3607450003116.
The STA - Liquid Anti-Xa kits are intended for use with STA-R, STA Compact and STA Satellite Analyzers for the quantitative determination of the plasma l Terminated |
KFF | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.