The following data is part of a premarket notification filed by Biochemical Trade, Inc. with the FDA for Cholesterol Determination.
| Device ID | K871260 |
| 510k Number | K871260 |
| Device Name: | CHOLESTEROL DETERMINATION |
| Classification | Enzymatic Esterase--oxidase, Cholesterol |
| Applicant | BIOCHEMICAL TRADE, INC. P.O. BOX 520575 Miami, FL 33152 |
| Contact | Alejo V Roy |
| Correspondent | Alejo V Roy BIOCHEMICAL TRADE, INC. P.O. BOX 520575 Miami, FL 33152 |
| Product Code | CHH |
| CFR Regulation Number | 862.1175 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-03-31 |
| Decision Date | 1987-04-13 |