510(k) K150528
- Device
- Cortisol Saliva Luminescence Immunoassay
- Applicant
- IBL INTERNATIONAL GMBH
- 510(k) number
- K150528
- Product code
- NHG
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2015-11-25
- Date received
- 2015-03-02
- Regulation
- 862.1205
- Classification name
- Enzyme Immunoassay, Cortisol, Salivary
- Medical specialty
- Clinical Chemistry
- Review panel
- Clinical Chemistry
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- NICOLA KAISER
- Address
- Flughafenstrasse 52 A Hamburg DE D-22335 D-22335
FDA Registration Numbers#
- 9610126
- 3003760091
- 9710337
- 2018685
- 3003559191
Source Documents#
Other 510(k) Records For Product Code NHG #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K102841 | PANTEX AM/PM SALIVARY CORTISOL ENZYME IMMUNOASSAY | Pantex, Div. Bio-Analysis, Inc. | 2012-05-08 |
| K070788 | ELECSYS CORTISOL TEST SYSTEM | Roche Diagnostics | 2007-10-05 |
| K051733 | ENZYME IMMUNOASSAY FOR THE DETECTION OF SALIVARY CORTISOL | Drg Intl., Inc. | 2005-12-07 |
| K043175 | ELECSYS CORTISOL TEST SYSTEM, ADDITION OF SALIVA SAMPLE TYPE | Roche Diagnostics Corp. | 2004-11-24 |
| K031348 | HIGH SENSITIVITY CORTISOL ENZYME IMMUNOASSAY | Salimetrics, LLC | 2003-06-10 |
| K011323 | HIGH SENSITIVITY CORTISOL ENZYME IMMUNOASSAY, MODEL 1-0101/1-0102 | Salimetrics, LLC | 2001-12-17 |
Legacy Summary#
summary
FDA Review#
Decision Summary