The following data is part of a premarket notification filed by Hycel, Inc. with the FDA for 17-hydroxy Test.
| Device ID | K772426 |
| 510k Number | K772426 |
| Device Name: | 17-HYDROXY TEST |
| Classification | Porter Silber Hydrazone, 17-hydroxycorticosteroids |
| Applicant | HYCEL, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | CDB |
| CFR Regulation Number | 862.1385 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1977-12-27 |
| Decision Date | 1978-01-30 |