The following data is part of a premarket notification filed by Sclavo, Inc. with the FDA for Cholesterol Test.
Device ID | K770265 |
510k Number | K770265 |
Device Name: | CHOLESTEROL TEST |
Classification | Enzymatic Esterase--oxidase, Cholesterol |
Applicant | SCLAVO, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | CHH |
CFR Regulation Number | 862.1175 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1977-02-11 |
Decision Date | 1977-02-25 |