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 17-a-hydroxyprogesterone.
| Device ID | K062534 |
| 510k Number | K062534 |
| Device Name: | ENZYME IMMUNOASSAY FOR THE DETECTION OF SALIVARY 17-A-HYDROXYPROGESTERONE |
| Classification | Radioimmunoassay, 17-hydroxyprogesterone |
| 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 | JLX |
| CFR Regulation Number | 862.1395 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-08-29 |
| Decision Date | 2008-01-29 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00404847431407 | K062534 | 000 |
| 00840239031402 | K062534 | 000 |
| 04048474031409 | K062534 | 000 |