The following data is part of a premarket notification filed by Amicon, Inc. with the FDA for Amicon Ultrafiltration Membranes Cmii.
Device ID | K810810 |
510k Number | K810810 |
Device Name: | AMICON ULTRAFILTRATION MEMBRANES CMII |
Classification | System, Test, Carcinoembryonic Antigen |
Applicant | AMICON, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | DHX |
CFR Regulation Number | 866.6010 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1981-03-24 |
Decision Date | 1981-04-17 |