Company ยท US
Amicon, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1976 to 1993. Name variants (Inc, Corp, punctuation) are merged.
20510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| KDI | Dialyzer, High Permeability With Or Without Sealed Dialysate System | 8 |
| JJH | Clinical Sample Concentrator | 6 |
| DHX | System, Test, Carcinoembryonic Antigen | 1 |
| JJP | Electrode, Ion Selective (Non-Specified) | 1 |
| JQQ | Dialyzer | 1 |
| JRL | Unit, Filter, Membrane | 1 |
| KJF | System, Suspension, Cell Culture | 1 |
| KPF | System, Dialysate Delivery, Semi-Automatic, Peritoneal | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Aug 5, 1993 | K930168 | CENTRICON -50 CONCENTRATOR Amicon, Inc. | JJH |
| Nov 1, 1990 | K902837 | AMICON DIAFILTER 30 HEMOCONCENTRATOR Amicon, Inc. | KDI |
| May 18, 1990 | K901286 | AMICON HEMOCONCENTRATOR SET Amicon, Inc. | KDI |
| Feb 16, 1990 | K900280 | CENTRIPREP 100 Amicon, Inc. | JJP |
| Jan 11, 1990 | K895405 | AMICON MINIFILTER PLUS HEMOFILTER Amicon, Inc. | KDI |
| Jul 20, 1989 | K893733 | CENTRICON CONCENTRATOR Amicon, Inc. | JJH |
| Jun 13, 1989 | K892645 | AMICON VITAFIBER FLO-PATH BIORECT/VLS CELL CULT SY Amicon, Inc. | KJF |
| Feb 19, 1988 | K875121 | AMICON EQUALINE FLUID BALANCE SYSTEM Amicon, Inc. | KPF |
| Mar 19, 1987 | K870690 | CENTRIPREP CONCENTRATOR Amicon, Inc. | JJH |
| Nov 6, 1986 | K863823 | AMICON DIAFILTER HEMOFILTER Amicon, Inc. | KDI |
| Sep 12, 1985 | K853510 | MINIFILTER HEMOFILTER Amicon, Inc. | KDI |
| Jan 30, 1984 | K833919 | CENTRICON MICRO-CONCENTRATOR Amicon, Inc. | JJH |
| Jan 17, 1983 | K823881 | ARTERIOVENOUS BLOOD TUBING SET FOR Amicon, Inc. | KDI |
| Dec 16, 1982 | K823288 | AMICON DIAFILTERS 20 & 30 HEMOFILTERS Amicon, Inc. | KDI |
| Mar 31, 1982 | K813591 | HEMOFILTERS Amicon, Inc. | KDI |
| Mar 15, 1982 | K820455 | CENTRIFREE MICROPARTITION SYSTEM Amicon, Inc. | JRL |
| Apr 17, 1981 | K810810 | AMICON ULTRAFILTRATION MEMBRANES CMII Amicon, Inc. | DHX |
| Apr 6, 1977 | K770398 | MINICON Amicon, Inc. | JJH |
| Dec 6, 1976 | K761100 | MULTI-CELL ULTRAFILTRATION SYSTEM Amicon, Inc. | JQQ |
| Nov 23, 1976 | K760592 | MINICON CONCENTRATOR Amicon, Inc. | JJH |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||