The following data is part of a premarket notification filed by Harleco with the FDA for Ultrachem E-glu, Manual Determ..
| Device ID | K780065 |
| 510k Number | K780065 |
| Device Name: | ULTRACHEM E-GLU, MANUAL DETERM. |
| Classification | Hexokinase, Glucose |
| Applicant | HARLECO 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | CFR |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1978-01-12 |
| Decision Date | 1978-02-01 |