The following data is part of a premarket notification filed by Salimetrics Llc. with the FDA for High Sensitivity Cortisol Enzyme Immunoassay, Model 1-0101/1-0102.
| Device ID | K011323 |
| 510k Number | K011323 |
| Device Name: | HIGH SENSITIVITY CORTISOL ENZYME IMMUNOASSAY, MODEL 1-0101/1-0102 |
| Classification | Enzyme Immunoassay, Cortisol, Salivary |
| Applicant | SALIMETRICS LLC. 101 INNOVATION BLVD. SUITE 302 State College, PA 16803 |
| Contact | Eve Schwartz |
| Correspondent | Eve Schwartz SALIMETRICS LLC. 101 INNOVATION BLVD. SUITE 302 State College, PA 16803 |
| Product Code | NHG |
| CFR Regulation Number | 862.1205 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-05-01 |
| Decision Date | 2001-12-17 |