The following data is part of a premarket notification filed by Corning Medical & Scientific with the FDA for Corning High Resolution Protein Electro.
Device ID | K843397 |
510k Number | K843397 |
Device Name: | CORNING HIGH RESOLUTION PROTEIN ELECTRO |
Classification | Electrophoretic, Protein Fractionation |
Applicant | CORNING MEDICAL & SCIENTIFIC 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | CEF |
CFR Regulation Number | 862.1630 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1984-08-29 |
Decision Date | 1984-09-14 |