The following data is part of a premarket notification filed by Pantex, Div. Bio-analysis, Inc. with the FDA for Pantex Am/pm Salivary Cortisol Enzyme Immunoassay.
| Device ID | K102841 |
| 510k Number | K102841 |
| Device Name: | PANTEX AM/PM SALIVARY CORTISOL ENZYME IMMUNOASSAY |
| Classification | Enzyme Immunoassay, Cortisol, Salivary |
| Applicant | PANTEX, DIV. BIO-ANALYSIS, INC. 1701 BERKELEY ST. Santa Monica, CA 90404 |
| Contact | Romulo Garza |
| Correspondent | Romulo Garza PANTEX, DIV. BIO-ANALYSIS, INC. 1701 BERKELEY ST. Santa Monica, CA 90404 |
| Product Code | NHG |
| CFR Regulation Number | 862.1205 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-09-29 |
| Decision Date | 2012-05-08 |
| Summary: | summary |