DPS 4 Dialyzer Preparation System
FDA 510(k) K955299 · Seratronics, Inc.
510(k) numberK955299
Submission
- Device name
- DPS 4 Dialyzer Preparation System
- Applicant
- Seratronics, Inc.
Walnut Creek, CA, US - Received
- November 20, 1995
- Decision date
- October 21, 1996
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- LIF – Dialyzer Reprocessing System
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.5820
- Specialty
- Gastroenterology, Urology
Other 510(k)s with product code LIF
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K091360 | Clearflux Dialyzer Reprocessing SystemLIF · Traditional | Novaflux Technologies | 11/03/2010SE |
| K043126 | Assist Header CleanerLIF · Traditional | Alcavis International, Inc. | 02/03/2005SE |
| K040660 | Sterichek Glutaraldehyde Reagent StripsLIF · Traditional | Hach Company | 11/15/2004SE |
| K033505 | Renaclean SH Dialyzer Cleaning SystemLIF · Traditional | Minntech Corp. | 04/27/2004SE |
| K024076 | Maky 21.1 Dialyzer Reprocessing SystemLIF · Traditional | Hdc Maquinolas, LLC | 09/26/2003SE |
| K013713 | Arm Automatic Reprocessing MachineLIF · Traditional | Alcavis International Incorporated | 07/15/2002SE |
| K992016 | Amukin DLIF · Traditional | Amuchina Intl., Inc. | 01/10/2000SE |
| K991851 | Renaclear Dialyzer Cleaning SystemLIF · Traditional | Minntech Corp. | 08/30/1999SE |
| K974426 | Potency Test Strips, Indicator Test StripsLIF · Traditional | Reprocessing Products Corp | 02/10/1999SE |
| K974798 | Sterichek(Tm) Residual Peroxide Reagent StrpsLIF · Traditional | Environmental Test Systems, Inc. | 03/20/1998SE |
More from Environmental Test Systems, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K931336 | DRS 4 Dialyzer Reprocessing SystemLIF · Traditional | 04/18/1996SE |
| K944539 | DRS 4 ND Dialyzer Reprocessing SystemLIF · Traditional | 11/29/1995SE |
| K923529 | DMS Data Management SYSTEM/DRS-4 Dialyzer ReprocesLIF · Traditional | 08/29/1994SE |
| K914580 | DRS-4 Dialyzer Reprocessing SystemLIF · Traditional | 02/24/1992SE |
| K874573 | Fresenius Puristeril 340 (TM)LIF · Traditional | 04/25/1988SE |
| K874872 | Fresenius Hemoflow F3, F4, F5, F7FJI · Traditional | 02/19/1988SE |
| K870725 | Fresenius Hemoflow F6 and F8FJI · Traditional | 05/01/1987SE |
| K870724 | Fresenius Hemoflow F60 and F80KDI · Traditional | 04/01/1987SE |
| K864587 | Fresenius Ultraflux AV400, AV600KDI · Traditional | 03/03/1987SE |
| K864169 | Fresenius Hemoflow F50 & F70KDI · Traditional | 11/06/1986SE |
Questions and answers
When was DPS 4 Dialyzer Preparation System cleared by the FDA?
DPS 4 Dialyzer Preparation System (K955299) received a 510(k) decision of Substantially Equivalent on October 21, 1996, 336 days after the submission was received.
What is the product code of K955299?
The FDA product code is LIF – Dialyzer Reprocessing System, a Class II (moderate risk) device regulated under 21 CFR 876.5820.