The following data is part of a premarket notification filed by Harleco with the FDA for Ultrachem E-chol, Item #65025.
Device ID | K813039 |
510k Number | K813039 |
Device Name: | ULTRACHEM E-CHOL, ITEM #65025 |
Classification | Enzymatic Esterase--oxidase, Cholesterol |
Applicant | HARLECO 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 | 1981-10-28 |
Decision Date | 1981-11-10 |