Home / 510(k) Clearances / K860026

510(k) K860026

ULTRAMAX III, DIALYZER REPROCESSING DEVICE by Medicorp, Inc. — Product Code LIF

K860026 is an FDA 510(k) premarket notification submitted by Medicorp, Inc. for the device "ULTRAMAX III, DIALYZER REPROCESSING DEVICE". The FDA issued a decision of Substantially Equivalent on March 14, 1986. The device falls under product code LIF (Dialyzer Reprocessing System), a Class II device regulated under 21 CFR 876.5820. Medicorp, Inc. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 14, 1986
Date Received
January 3, 1986
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 Medicorp, Inc.

  • K844850 — MEDICORP DEHYDRACON A DEHYDRATED DIALYSATE CONCENT (April 2, 1985)
  • K832705 — ULTRAMAX (June 25, 1984)
  • K791164 — NEGATOVE PRESSURE CONVERTOR (October 4, 1979)
  • K791396 — MEDI-TRAK PORTABLE TRACTION DEVICE (August 16, 1979)

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