510(k) K150528 ยท NHG Enzyme Immunoassay, Cortisol, Salivary
Cortisol Saliva Luminescence Immunoassay
| Applicant | Ibl International GmbH, Hamburg, DE |
| Decision | Substantially Equivalent, Nov 25, 2015 |
| Received | Mar 2, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K150528
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 12, 2018 | Tecan US, Inc. Cortisol Saliva Luminescence Immunoassay
The IBL International Cortisol Saliva Luminescence immunoassay is intended for the in-vitro diagnostic quantitative determination of Cortisol in human saliva Terminated |
NHG | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.