The following data is part of a premarket notification filed by J.t. Baker Chemical Co. with the FDA for Autozyme Glucose Oxidase (trinder).
| Device ID | K772308 |
| 510k Number | K772308 |
| Device Name: | AUTOZYME GLUCOSE OXIDASE (TRINDER) |
| Classification | Glucose Oxidase, Glucose |
| Applicant | J.T. BAKER CHEMICAL CO. 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 | 1977-12-16 |
| Decision Date | 1978-03-03 |