The following data is part of a premarket notification filed by Electrophoresis Corp. Of America with the FDA for Eca Prep.
Device ID | K781117 |
510k Number | K781117 |
Device Name: | ECA PREP |
Classification | Electrophoretic, Protein Fractionation |
Applicant | ELECTROPHORESIS CORP. OF AMERICA 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 | 1978-07-03 |
Decision Date | 1978-08-10 |