510(k) K954591 ยท JFT Fluorometric, Cortisol
AIA-PACK CORT ASSAY
| Applicant | Tosoh Medics, Inc., Foster City CA, US |
| Decision | Substantially Equivalent, Dec 15, 1995 |
| Received | Oct 2, 1995 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K954591
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 5, 2018 | Tosoh Bioscience Inc ST-AIA PACK Cort; Part Number: 025287
Assay, Metabolic Terminated |
JFT | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.