The following data is part of a premarket notification filed by Catachem, Inc. with the FDA for Cholesterol Method.
| Device ID | K852863 |
| 510k Number | K852863 |
| Device Name: | CHOLESTEROL METHOD |
| Classification | Enzymatic Esterase--oxidase, Cholesterol |
| Applicant | CATACHEM, INC. 6 NORTH PEARL ST. Port Chester, NY 10573 |
| Contact | Luis Leon |
| Correspondent | Luis Leon CATACHEM, INC. 6 NORTH PEARL ST. Port Chester, NY 10573 |
| Product Code | CHH |
| CFR Regulation Number | 862.1175 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-07-08 |
| Decision Date | 1985-07-23 |