The following data is part of a premarket notification filed by Hycel, Inc. with the FDA for Ketosteroid Test, Hycel-17.
| Device ID | K782116 |
| 510k Number | K782116 |
| Device Name: | KETOSTEROID TEST, HYCEL-17 |
| Classification | Zimmerman (spectrophotometric), 17-ketosteroids |
| Applicant | HYCEL, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | CCY |
| CFR Regulation Number | 862.1430 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1978-12-27 |
| Decision Date | 1979-01-26 |