The following data is part of a premarket notification filed by Sartorius Filters, Inc. with the FDA for Sartophor System For Electrophoresis.
Device ID | K823132 |
510k Number | K823132 |
Device Name: | SARTOPHOR SYSTEM FOR ELECTROPHORESIS |
Classification | Apparatus, Electrophoresis, For Clinical Use |
Applicant | SARTORIUS FILTERS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | JJN |
CFR Regulation Number | 862.2485 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1982-10-25 |
Decision Date | 1982-11-27 |