The following data is part of a premarket notification filed by Baker Diagnostics with the FDA for Centrichem Cholesterol Reagent & Calibra.
| Device ID | K812293 |
| 510k Number | K812293 |
| Device Name: | CENTRICHEM CHOLESTEROL REAGENT & CALIBRA |
| Classification | Enzymatic Esterase--oxidase, Cholesterol |
| Applicant | BAKER DIAGNOSTICS 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 | 1981-08-13 |
| Decision Date | 1981-08-31 |