LIF — Dialyzer Reprocessing System Class II
FDA product code LIF covers "Dialyzer Reprocessing System", a Class II medical device regulated under 21 CFR 876.5820. Submissions are reviewed by the Gastroenterology, Urology panel. At least 20 recent 510(k) clearances have been granted under this product code.
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 |