510(k) K093960 ยท NDY Test, Cystatin C
ST AIA-PACK CYSTATIN C, MODEL 025217
| Applicant | Tosoh Bioscience, Inc., South San Franciso CA, US |
| Decision | Substantially Equivalent, Sep 14, 2010 |
| Received | Dec 23, 2009 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K093960
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 5, 2018 | Tosoh Bioscience Inc ST-AIA PACK Cystatin C; Part Number: 025217
Assay, Kidney Marker Terminated |
NDY | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.