The following data is part of a premarket notification filed by Amicon, Inc. with the FDA for Centricon -50 Concentrator.
| Device ID | K930168 |
| 510k Number | K930168 |
| Device Name: | CENTRICON -50 CONCENTRATOR |
| Classification | Clinical Sample Concentrator |
| Applicant | AMICON, INC. 72 CHERRY HILL DR. Danvers, MA 01923 |
| Contact | James M Delaney |
| Correspondent | James M Delaney AMICON, INC. 72 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 | 1993-01-13 |
| Decision Date | 1993-08-05 |