The following data is part of a premarket notification filed by Drg Intl., Inc. with the FDA for Drg Slv Testosterone Elisa Test.
| Device ID | K052649 |
| 510k Number | K052649 |
| Device Name: | DRG SLV TESTOSTERONE ELISA TEST |
| Classification | Radioimmunoassay, Testosterones And Dihydrotestosterone |
| 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 | CDZ |
| CFR Regulation Number | 862.1680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-09-26 |
| Decision Date | 2006-01-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00404847430134 | K052649 | 000 |
| 00840239030139 | K052649 | 000 |
| 04048474030136 | K052649 | 000 |