The following data is part of a premarket notification filed by Salimetrics Llc. with the FDA for High Sensitivity Cortisol Enzyme Immunoassay.
| Device ID | K031348 |
| 510k Number | K031348 |
| Device Name: | HIGH SENSITIVITY CORTISOL ENZYME IMMUNOASSAY |
| Classification | Enzyme Immunoassay, Cortisol, Salivary |
| Applicant | SALIMETRICS LLC. 101 INNOVATION BLVD. SUITE 302 State College, PA 16803 -6605 |
| Contact | Eve Schwartz |
| Correspondent | Eve Schwartz SALIMETRICS LLC. 101 INNOVATION BLVD. SUITE 302 State College, PA 16803 -6605 |
| Product Code | NHG |
| CFR Regulation Number | 862.1205 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-04-11 |
| Decision Date | 2003-06-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00859410006030 | K031348 | 000 |
| 00859410006023 | K031348 | 000 |
| 00859410006016 | K031348 | 000 |