The following data is part of a premarket notification filed by Alpkem Corp. with the FDA for Total Cholesterol Reagent.
| Device ID | K890334 |
| 510k Number | K890334 |
| Device Name: | TOTAL CHOLESTEROL REAGENT |
| Classification | Enzymatic Esterase--oxidase, Cholesterol |
| Applicant | ALPKEM CORP. BOX 1260 Clackamas, OR 97015 |
| Contact | Raymond L Pavitt |
| Correspondent | Raymond L Pavitt ALPKEM CORP. BOX 1260 Clackamas, OR 97015 |
| Product Code | CHH |
| CFR Regulation Number | 862.1175 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-01-23 |
| Decision Date | 1989-05-03 |