The following data is part of a premarket notification filed by Harleco with the FDA for Ultrachem Gluc-dh.
| Device ID | K813427 |
| 510k Number | K813427 |
| Device Name: | ULTRACHEM GLUC-DH |
| Classification | Glucose Dehydrogenase, Glucose |
| Applicant | HARLECO 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | LFR |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-12-07 |
| Decision Date | 1981-12-31 |