The following data is part of a premarket notification filed by Sclavo, Inc. with the FDA for Fast Cholesterol (total Cholesterol Test).
| Device ID | K862507 |
| 510k Number | K862507 |
| Device Name: | FAST CHOLESTEROL (TOTAL CHOLESTEROL TEST) |
| Classification | Enzymatic Esterase--oxidase, Cholesterol |
| Applicant | SCLAVO, INC. 5 MANSARD COURT Wayne, NJ 07470 |
| Contact | Debra Hofmeister |
| Correspondent | Debra Hofmeister SCLAVO, INC. 5 MANSARD COURT Wayne, NJ 07470 |
| Product Code | CHH |
| CFR Regulation Number | 862.1175 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-07-01 |
| Decision Date | 1986-07-16 |