The following data is part of a premarket notification filed by Drg Intl., Inc. with the FDA for Drg Aurica Elisa Testosterone Kit.
| Device ID | K000043 |
| 510k Number | K000043 |
| Device Name: | DRG AURICA ELISA TESTOSTERONE KIT |
| Classification | Radioimmunoassay, Testosterones And Dihydrotestosterone |
| Applicant | DRG INTL., INC. 150 CHERRY LANE RD. East Stroudsburg, PA 18301 |
| Contact | Nikolas Butkov |
| Correspondent | Nikolas Butkov 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 | 2000-01-06 |
| Decision Date | 2000-04-17 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00404847415599 | K000043 | 000 |
| 00840239015594 | K000043 | 000 |
| 04048474015591 | K000043 | 000 |