The following data is part of a premarket notification filed by Amicon, Inc. with the FDA for Centriprep Concentrator.
Device ID | K870690 |
510k Number | K870690 |
Device Name: | CENTRIPREP CONCENTRATOR |
Classification | Clinical Sample Concentrator |
Applicant | AMICON, INC. 17 CHERRY HILL DR. Danvers, MA 01923 |
Contact | James M Delaney |
Correspondent | James M Delaney AMICON, INC. 17 CHERRY HILL DR. Danvers, MA 01923 |
Product Code | JJH |
CFR Regulation Number | 862.2310 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-02-19 |
Decision Date | 1987-03-19 |