The following data is part of a premarket notification filed by Eppendorf-brinkmann, Inc. with the FDA for Urinary 17-ketosteriod/17.
| Device ID | K772337 |
| 510k Number | K772337 |
| Device Name: | URINARY 17-KETOSTERIOD/17 |
| Classification | Chromatography Separation/zimmerman 17-ketogenic Steroids |
| Applicant | EPPENDORF-BRINKMANN, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | CDG |
| CFR Regulation Number | 862.1385 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1977-12-22 |
| Decision Date | 1978-01-12 |