The following data is part of a premarket notification filed by Fisher Scientific Co., Llc. with the FDA for Cholesterol Det. In Serum.
Device ID | K781611 |
510k Number | K781611 |
Device Name: | CHOLESTEROL DET. IN SERUM |
Classification | Lieberman-burchard/abell-kendall, Colorimetric, Cholesterol |
Applicant | FISHER SCIENTIFIC CO., LLC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | CGO |
CFR Regulation Number | 862.1175 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1978-09-19 |
Decision Date | 1978-10-24 |