510(k) K060548 ยท DHA System, Test, Human Chorionic Gonadotropin
STRATUS CS ACUTE CARE BETAHCG AND NT-PROBNP TESTPAK AND TESTPAK ASSAY, CALPAK AND DILPAK
| Applicant | Dade Behring, Inc., Newark DE, US |
| Decision | Substantially Equivalent, Apr 6, 2006 |
| Received | Mar 1, 2006 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K060548
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 7, 2016 | Siemens Healthcare Diagnostics Inc Siemens Acute Care BHCG TestPak-an in vitro diagnostic product intended to be used for calibration of the Stratus CS Acute Care hCG method
Catalog Number: CBHCG
SMN:10445060 Terminated |
DHA | None listed |
| Jan 7, 2016 | Siemens Healthcare Diagnostics Inc Siemens Acute Care BHCG CalPak-in vitro diagnostic product intended to be used for calibration of the Stratus CS Acute Care rM ~ h CG method
Catalog Number: CBHCG-C
SMN:10445061 Terminated |
DHA | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.