The following data is part of a premarket notification filed by Harleco with the FDA for Acr Enzymatic Glucose Oxidase.
| Device ID | K812258 |
| 510k Number | K812258 |
| Device Name: | ACR ENZYMATIC GLUCOSE OXIDASE |
| Classification | Glucose Oxidase, Glucose |
| Applicant | HARLECO 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | CGA |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-08-12 |
| Decision Date | 1981-08-31 |