The following data is part of a premarket notification filed by Harleco with the FDA for Gemsaec Appli. For Ultrazyme Plus Y-amyl.
| Device ID | K772035 |
| 510k Number | K772035 |
| Device Name: | GEMSAEC APPLI. FOR ULTRAZYME PLUS Y-AMYL |
| Classification | Catalytic Methods, Amylase |
| Applicant | HARLECO 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | JFJ |
| CFR Regulation Number | 862.1070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1977-10-27 |
| Decision Date | 1977-11-17 |