Company ยท US
Seratronics, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1982 to 1996. Name variants (Inc, Corp, punctuation) are merged.
21510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| LIF | Dialyzer Reprocessing System | 9 |
| KDI | Dialyzer, High Permeability With Or Without Sealed Dialysate System | 6 |
| FJI | Dialyzer, Capillary, Hollow Fiber | 2 |
| FKQ | System, Dialysate Delivery, Central Multiple Patient | 2 |
| FJK | Set, Tubing, Blood, With And Without Anti-Regurgitation Valve | 1 |
| FLC | Station, Dialysis Control, Negative Pressure Type | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Oct 21, 1996 | K955299 | DPS 4 DIALYZER PREPARATION SYSTEM Seratronics, Inc. | LIF |
| Apr 18, 1996 | K931336 | DRS 4 DIALYZER REPROCESSING SYSTEM Seratronics, Inc. | LIF |
| Nov 29, 1995 | K944539 | DRS 4 ND DIALYZER REPROCESSING SYSTEM Seratronics, Inc. | LIF |
| Aug 29, 1994 | K923529 | DMS DATA MANAGEMENT SYSTEM/DRS-4 DIALYZER REPROCES Seratronics, Inc. | LIF |
| Feb 24, 1992 | K914580 | DRS-4 DIALYZER REPROCESSING SYSTEM Seratronics, Inc. | LIF |
| Apr 25, 1988 | K874573 | FRESENIUS PURISTERIL 340 (TM) Seratronics, Inc. | LIF |
| Feb 19, 1988 | K874872 | FRESENIUS HEMOFLOW F3, F4, F5, F7 Seratronics, Inc. | FJI |
| May 1, 1987 | K870725 | FRESENIUS HEMOFLOW F6 AND F8 Seratronics, Inc. | FJI |
| Apr 1, 1987 | K870724 | FRESENIUS HEMOFLOW F60 AND F80 Seratronics, Inc. | KDI |
| Mar 3, 1987 | K864587 | FRESENIUS ULTRAFLUX AV400, AV600 Seratronics, Inc. | KDI |
| Nov 6, 1986 | K864169 | FRESENIUS HEMOFLOW F50 & F70 Seratronics, Inc. | KDI |
| Apr 7, 1986 | K861106 | FRESENIUS HEMOFLOW F80 DIALYZER Seratronics, Inc. | KDI |
| Apr 7, 1986 | K860674 | DRS-4 DIALYZER REPROCESSING SYSTEM Seratronics, Inc. | LIF |
| Jan 21, 1986 | K855001 | FRESENIUS HEMODIALYSIS MACHINE A1008 BSM Seratronics, Inc. | FLC |
| Nov 12, 1985 | K853851 | FRESENIUS DISPOSABLE BLOOD LINES Seratronics, Inc. | FJK |
| Jul 25, 1985 | K852251 | FRESENIUS HEMOFLOW F60 & FRESENIUS HEMOFLOW F40 Seratronics, Inc. | KDI |
| Feb 15, 1985 | K844750 | FRESENIUS A2008 HEMODIALYSIS MACHINE EXPANSION MOD Seratronics, Inc. | FKQ |
| Feb 14, 1985 | K844641 | FRESENIUS HAEMODIALYSIS ;MACHINE A1008 Seratronics, Inc. | FKQ |
| Oct 18, 1984 | K843014 | FRESENIUS HAEMODIALYSIS A2008 Seratronics, Inc. | KDI |
| Oct 14, 1983 | K832230 | DIALYZER PREPARATION SYS DPS-4 Seratronics, Inc. | LIF |
| Oct 18, 1982 | K821863 | DIALYZER REPROCESSING SYSTEM DRS-4 Seratronics, Inc. | LIF |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||