Pantex Am/Pm Salivary Cortisol Enzyme Immunoassay
FDA 510(k) K102841 · Pantex, Div. Bio-Analysis, Inc.
Submission
- Device name
- Pantex Am/Pm Salivary Cortisol Enzyme Immunoassay
- Applicant
- Pantex, Div. Bio-Analysis, Inc.
Santa Monica, CA, US - Received
- September 29, 2010
- Decision date
- May 8, 2012
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- NHG – Enzyme Immunoassay, Cortisol, Salivary
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1205
- Specialty
- Clinical Chemistry
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…
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Questions and answers
When was Pantex Am/Pm Salivary Cortisol Enzyme Immunoassay cleared by the FDA?
Pantex Am/Pm Salivary Cortisol Enzyme Immunoassay (K102841) received a 510(k) decision of Substantially Equivalent on May 8, 2012, 587 days after the submission was received.
What is the product code of K102841?
The FDA product code is NHG – Enzyme Immunoassay, Cortisol, Salivary, a Class II (moderate risk) device regulated under 21 CFR 862.1205.