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510(k) K853413

RENNEW-D SPORICIDE/DISINFECTANT FOR HEMODIALYZERS by Alcide Corp. — Product Code LIF

K853413 is an FDA 510(k) premarket notification submitted by Alcide Corp. for the device "RENNEW-D SPORICIDE/DISINFECTANT FOR HEMODIALYZERS". The FDA issued a decision of Substantially Equivalent on September 6, 1985. The device falls under product code LIF (Dialyzer Reprocessing System), a Class II device regulated under 21 CFR 876.5820. Alcide Corp. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 6, 1985
Date Received
August 14, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Dialyzer Reprocessing System
Device Class
Class II
Regulation Number
876.5820
Review Panel
GU
Submission Type

Other clearances by Alcide Corp.

  • K952929 — LD GENERAL PURPOSE DISINFECTANT (October 7, 1995)
  • K953241 — EXSPOR (September 29, 1995)
  • K844734 — ALCIDE REN NEW-D (May 17, 1985)

Other clearances for product code LIF

  • K091360 — CLEARFLUX DIALYZER REPROCESSING SYSTEM (November 3, 2010)
  • K043126 — ASSIST HEADER CLEANER (February 3, 2005)
  • K040660 — STERICHEK GLUTARALDEHYDE REAGENT STRIPS (November 15, 2004)
  • K033505 — RENACLEAN SH DIALYZER CLEANING SYSTEM (April 27, 2004)
  • K024076 — MAKY 21.1 DIALYZER REPROCESSING SYSTEM (September 26, 2003)
  • K013713 — ARM AUTOMATIC REPROCESSING MACHINE (July 15, 2002)
  • K992016 — AMUKIN D (January 10, 2000)
  • K991851 — RENACLEAR DIALYZER CLEANING SYSTEM (August 30, 1999)
  • K974426 — POTENCY TEST STRIPS, INDICATOR TEST STRIPS (February 10, 1999)
  • K974798 — STERICHEK(TM) RESIDUAL PEROXIDE REAGENT STRPS (March 20, 1998)

FDA data resources