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510(k) K992016

AMUKIN D by Amuchina Intl., Inc. — Product Code LIF

K992016 is an FDA 510(k) premarket notification submitted by Amuchina Intl., Inc. for the device "AMUKIN D". The FDA issued a decision of Substantially Equivalent on January 10, 2000. The device falls under product code LIF (Dialyzer Reprocessing System), a Class II device regulated under 21 CFR 876.5820. Amuchina Intl., Inc. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 10, 2000
Date Received
June 15, 1999
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 Amuchina Intl., Inc.

  • K952302 — AMUCHINA (July 26, 1995)
  • K871583 — MODIFIED LABELING FOR AMUKIN-50% (July 9, 1987)
  • K862928 — AMUKIN-50% FOR CAPD Y-SET (March 9, 1987)
  • K852359 — AMUCHINA/DIALYZER DISINFECTANT (May 13, 1986)

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)
  • 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