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510(k) K013713

ARM AUTOMATIC REPROCESSING MACHINE by Alcavis International Incorporated — Product Code LIF

K013713 is an FDA 510(k) premarket notification submitted by Alcavis International Incorporated for the device "ARM AUTOMATIC REPROCESSING MACHINE". The FDA issued a decision of Substantially Equivalent on July 15, 2002. The device falls under product code LIF (Dialyzer Reprocessing System), a Class II device regulated under 21 CFR 876.5820.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 15, 2002
Date Received
November 8, 2001
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 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)
  • 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)
  • K970799 — ALEXANDER MANUFACTURING RECHARGEABLE BATTERY (M1/T) (May 14, 1997)

FDA data resources