The following data is part of a premarket notification filed by Medisense, Inc. with the FDA for Satellite C Blood Cholesterol Monitoring System.
| Device ID | K896467 |
| 510k Number | K896467 |
| Device Name: | SATELLITE C BLOOD CHOLESTEROL MONITORING SYSTEM |
| Classification | Enzymatic Esterase--oxidase, Cholesterol |
| Applicant | MEDISENSE, INC. 128 SIDNEY ST. Cambridge, MA 02139 |
| Contact | Lias, Phd |
| Correspondent | Lias, Phd MEDISENSE, INC. 128 SIDNEY ST. Cambridge, MA 02139 |
| Product Code | CHH |
| CFR Regulation Number | 862.1175 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-11-13 |
| Decision Date | 1990-06-12 |