The following data is part of a premarket notification filed by Amicon, Inc. with the FDA for Minicon Concentrator.
Device ID | K760592 |
510k Number | K760592 |
Device Name: | MINICON CONCENTRATOR |
Classification | Clinical Sample Concentrator |
Applicant | AMICON, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | JJH |
CFR Regulation Number | 862.2310 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1976-09-07 |
Decision Date | 1976-11-23 |