510(k) K081074 ยท JLW Radioimmunoassay, Thyroid-Stimulating Hormone
DIMENSION TSHL FLEX REAGENT CARTRIDGE AND TSH SAMPLE DILUENT WITH MODELS RF 612 AND KD691
| Applicant | Siemens Healthcare Diagnostics, Inc., Newark DE, US |
| Decision | Substantially Equivalent, May 23, 2008 |
| Received | Apr 16, 2008 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K081074
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 6, 2013 | Siemens Healthcare Diagnostics, Inc Dimension TSH Flex Reagent Cartridge (REF RF412).
Intended to quantitatively measure human thyroid stimulating hormone (TSH, thyrotropin). Terminated |
JLW | None listed |
| Aug 6, 2013 | Siemens Healthcare Diagnostics, Inc Dimension EXL LOCI Module TSHL Flex Reagent Cartridge (REF RF612).
Intended to quantitatively measure human thyroid stimulating hormone (TSH, thyrotropin). Terminated |
JLW | None listed |
| Nov 24, 2010 | Siemens Healthcare Diagnostics, Inc. The Dimension TSHL Flex reagent cartridge (Thyroid Stimulating Hormone) manufactured by Siemens Healthcare Diagnostics, Inc., Newark, DE. Terminated |
JLW | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.