Panels › Clinical Chemistry › Product code NHG · Class 2
Enzyme Immunoassay, Cortisol, Salivary
Regulation 862.1205
0510(k)s in 12 months (7 all time)
3recalls in 12 months (5 all time)
2recalls that name a 510(k)
Top companies in NHG
| Company | 510(k)s | Recalls |
|---|---|---|
| GET TESTED INTERNATIONAL AB | 0 | 3 |
| Roche Diagnostics | 2 | 1 |
| Salimetrics, LLC | 2 | 0 |
| Drg Intl., Inc. | 1 | 0 |
| Ibl International GmbH | 1 | 0 |
| Pantex, Div. Bio-Analysis, Inc. | 1 | 0 |
| Tecan US, Inc. | 0 | 1 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 1, 2025 | GET TESTED INTERNATIONAL AB Allergy test Small Open, Classified |
NHG | None listed |
| Dec 1, 2025 | GET TESTED INTERNATIONAL AB Women s Hormone Test Open, Classified |
NHG | None listed |
| Dec 1, 2025 | GET TESTED INTERNATIONAL AB Adrenal Test Open, Classified |
NHG | None listed |
| 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 | K150528 |
| Jun 28, 2007 | Roche Diagnostics Corp. Roche Cortisol reagent for use in conjunction with Roche cobas e 411, cobas e 601, Elecsys 1010, Elecsys 2010 and Modular E 170 analyzers; Catalog no. 11875116122. in vitro diagnostic. Terminated |
NHG | K043175 |
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