510(k) K031348
K031348 is an FDA 510(k) premarket notification submitted by Salimetrics, LLC for the device "HIGH SENSITIVITY CORTISOL ENZYME IMMUNOASSAY". The FDA issued a decision of Substantially Equivalent on June 10, 2003. The device falls under product code NHG (Enzyme Immunoassay, Cortisol, Salivary), a Class II device regulated under 21 CFR 862.1205. Salimetrics, LLC has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 10, 2003
- Date Received
- April 11, 2003
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Enzyme Immunoassay, Cortisol, Salivary
- Device Class
- Class II
- Regulation Number
- 862.1205
- Review Panel
- CH
- Submission Type
The HS Salivary Cortisol Enzyme Immunoassay Kit is for the quantitative in vitro diagnostic measurement of salivary cortisol. This kit may be used to measure adrenal cortical function and as a screen for Cushing's and Addison's Disease. This kit is not intended for use with serum or plasma samples. The device's intended use differs from the description in the classification regulation in that it is for use with saliva samples.