The following data is part of a premarket notification filed by Amicon, Inc. with the FDA for Centricon Micro-concentrator.
Device ID | K833919 |
510k Number | K833919 |
Device Name: | CENTRICON MICRO-CONCENTRATOR |
Classification | Clinical Sample Concentrator |
Applicant | AMICON, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
Product Code | JJH |
CFR Regulation Number | 862.2310 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1983-11-14 |
Decision Date | 1984-01-30 |