The following data is part of a premarket notification filed by Drg Intl., Inc. with the FDA for Enzyme Immunoassay For The Detection Of Salivary Cortisol.
| Device ID | K051733 |
| 510k Number | K051733 |
| Device Name: | ENZYME IMMUNOASSAY FOR THE DETECTION OF SALIVARY CORTISOL |
| Classification | Enzyme Immunoassay, Cortisol, Salivary |
| Applicant | DRG INTL., INC. 150 CHERRY LANE RD. East Stroudsburg, PA 18301 |
| Contact | Gary Lehnus |
| Correspondent | Gary Lehnus DRG INTL., INC. 150 CHERRY LANE RD. East Stroudsburg, PA 18301 |
| Product Code | NHG |
| CFR Regulation Number | 862.1205 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-06-28 |
| Decision Date | 2005-12-07 |
| Summary: | summary |