The following data is part of a premarket notification filed by Worthington Biochemical Corp. with the FDA for Statzyme Glucose.
| Device ID | K771001 |
| 510k Number | K771001 |
| Device Name: | STATZYME GLUCOSE |
| Classification | Glucose Oxidase, Glucose |
| Applicant | WORTHINGTON BIOCHEMICAL CORP. 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 | 1977-06-03 |
| Decision Date | 1977-07-11 |