510(k) K031348
- Device
- HIGH SENSITIVITY CORTISOL ENZYME IMMUNOASSAY
- Applicant
- SALIMETRICS LLC.
- 510(k) number
- K031348
- Product code
- NHG
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2003-06-10
- Date received
- 2003-04-11
- Regulation
- 862.1205
- Classification name
- Enzyme Immunoassay, Cortisol, Salivary
- Medical specialty
- Clinical Chemistry
- Review panel
- Clinical Chemistry
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- EVE SCHWARTZ
- Address
- 101 Innovation Blvd., Suite 302 State College PA US 16803 16803
FDA Registration Numbers#
- 9610126
- 3003760091
- 9710337
- 2018685
- 3003559191
Source Documents#
Other 510(k) Records For Product Code NHG #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K150528 | Cortisol Saliva Luminescence Immunoassay | Ibl International GmbH | 2015-11-25 |
| 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 |
| K011323 | HIGH SENSITIVITY CORTISOL ENZYME IMMUNOASSAY, MODEL 1-0101/1-0102 | Salimetrics, LLC | 2001-12-17 |
Legacy Summary#
summary
FDA Review#
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