LIF — Dialyzer Reprocessing System Class II
FDA Device Classification
Classification Details
- Product Code
- LIF
- Device Class
- Class II
- Regulation Number
- 876.5820
- Submission Type
- Review Panel
- GU
- Medical Specialty
- Gastroenterology, Urology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|
| K091360 | novaflux technologies | CLEARFLUX DIALYZER REPROCESSING SYSTEM | November 3, 2010 |
| K043126 | alcavis international | ASSIST HEADER CLEANER | February 3, 2005 |
| K040660 | hach | STERICHEK GLUTARALDEHYDE REAGENT STRIPS | November 15, 2004 |
| K033505 | minntech | RENACLEAN SH DIALYZER CLEANING SYSTEM | April 27, 2004 |
| K024076 | hdc maquinolas | MAKY 21.1 DIALYZER REPROCESSING SYSTEM | September 26, 2003 |
| K013713 | alcavis international incorporated | ARM AUTOMATIC REPROCESSING MACHINE | July 15, 2002 |
| K992016 | amuchina intl | AMUKIN D | January 10, 2000 |
| K991851 | minntech | RENACLEAR DIALYZER CLEANING SYSTEM | August 30, 1999 |
| K974426 | reprocessing products | POTENCY TEST STRIPS, INDICATOR TEST STRIPS | February 10, 1999 |
| K974798 | environmental test systems | STERICHEK(TM) RESIDUAL PEROXIDE REAGENT STRPS | March 20, 1998 |
| K970799 | alexander mfg | ALEXANDER MANUFACTURING RECHARGEABLE BATTERY (M1/T) | May 14, 1997 |
| K955299 | seratronics | DPS 4 DIALYZER PREPARATION SYSTEM | October 21, 1996 |
| K931336 | seratronics | DRS 4 DIALYZER REPROCESSING SYSTEM | April 18, 1996 |
| K941757 | national medical care, medical products div | FORMALIN REUSE CART | January 22, 1996 |
| K941867 | renal scientific service | RENALIN REUSE CART | January 22, 1996 |
| K944539 | seratronics | DRS 4 ND DIALYZER REPROCESSING SYSTEM | November 29, 1995 |
| K944492 | g.e.m. water systems | DIALYZER REPROCESSING SYSTEM | August 28, 1995 |
| K923529 | seratronics | DMS DATA MANAGEMENT SYSTEM/DRS-4 DIALYZER REPROCES | August 29, 1994 |
| K914123 | serim research | SERIM RESIDUAL FORMALDEHYDE REAGENT STRIPS | April 9, 1992 |
| K914580 | seratronics | DRS-4 DIALYZER REPROCESSING SYSTEM | February 24, 1992 |