The following data is part of a premarket notification filed by Corning Medical & Scientific with the FDA for Cholesterol Reagent Substrate Set.
Device ID | K781970 |
510k Number | K781970 |
Device Name: | CHOLESTEROL REAGENT SUBSTRATE SET |
Classification | Electrophoretic Separation, Lipoproteins |
Applicant | CORNING MEDICAL & SCIENTIFIC 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | JHO |
CFR Regulation Number | 862.1475 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1978-11-24 |
Decision Date | 1979-01-03 |