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 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Nov 25, 2015 | K150528 | Cortisol Saliva Luminescence Immunoassay Ibl International GmbH, DE | NHG |
| May 8, 2012 | K102841 | PANTEX AM/PM SALIVARY CORTISOL ENZYME IMMUNOASSAY Pantex, Div. Bio-Analysis, Inc. | NHG |
| Oct 5, 2007 | K070788 | ELECSYS CORTISOL TEST SYSTEM Roche Diagnostics | NHG |
| Dec 7, 2005 | K051733 | ENZYME IMMUNOASSAY FOR THE DETECTION OF SALIVARY CORTISOL Drg Intl., Inc. | NHG |
| Nov 24, 2004 | K043175 | ELECSYS CORTISOL TEST SYSTEM, ADDITION OF SALIVA SAMPLE TYPE Roche Diagnostics Corp. | NHG |
| Jun 10, 2003 | K031348 | HIGH SENSITIVITY CORTISOL ENZYME IMMUNOASSAY Salimetrics, LLC | NHG |
| Dec 17, 2001 | K011323 | HIGH SENSITIVITY CORTISOL ENZYME IMMUNOASSAY, MODEL 1-0101/1-0102 Salimetrics, LLC | NHG |
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