The following data is part of a premarket notification filed by American Research Products Co. with the FDA for Liquizyme Glucose Reagent.
| Device ID | K813168 |
| 510k Number | K813168 |
| Device Name: | LIQUIZYME GLUCOSE REAGENT |
| Classification | Glucose Oxidase, Glucose |
| Applicant | AMERICAN RESEARCH PRODUCTS CO. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | CGA |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-11-16 |
| Decision Date | 1981-12-03 |