The following data is part of a premarket notification filed by J.t. Baker Chemical Co. with the FDA for Autozyme Cholesterol-oxidase Reagent Kit.
| Device ID | K780783 |
| 510k Number | K780783 |
| Device Name: | AUTOZYME CHOLESTEROL-OXIDASE REAGENT KIT |
| Classification | Enzymatic Esterase--oxidase, Cholesterol |
| Applicant | J.T. BAKER CHEMICAL CO. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | CHH |
| CFR Regulation Number | 862.1175 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1978-05-12 |
| Decision Date | 1978-06-06 |