FDA Product Code
FDA Product Code NHG — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Clinical Chemistry
- 21 CFR Citation
- 862.1205
510(k) Clearances — 7 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K150528 | Cortisol Saliva Luminescence Immunoassay | Ibl International GmbH | 2015-11-25 | Traditional | PDF ↗ |
| K102841 | PANTEX AM/PM SALIVARY CORTISOL ENZYME IMMUNOASSAY | Pantex, Div. Bio-Analysis, Inc. | 2012-05-08 | Traditional | PDF ↗ |
| K070788 | ELECSYS CORTISOL TEST SYSTEM | Roche Diagnostics | 2007-10-05 | Traditional | PDF ↗ |
| K051733 | ENZYME IMMUNOASSAY FOR THE DETECTION OF SALIVARY CORTISOL | Drg Intl., Inc. | 2005-12-07 | Traditional | PDF ↗ |
| K043175 | ELECSYS CORTISOL TEST SYSTEM, ADDITION OF SALIVA SAMPLE TYPE | Roche Diagnostics Corp. | 2004-11-24 | Traditional | PDF ↗ |
| K031348 | HIGH SENSITIVITY CORTISOL ENZYME IMMUNOASSAY | Salimetrics, LLC | 2003-06-10 | Special | PDF ↗ |
| K011323 | HIGH SENSITIVITY CORTISOL ENZYME IMMUNOASSAY, MODEL 1-0101/1-0102 | Salimetrics, LLC | 2001-12-17 | Traditional | PDF ↗ |
Product code NHG · Class II · Clinical Chemistry. Data: openFDA.