Home / 510(k) Clearances / K850127

510(k) K850127

FORMA-TAG USP SODIUM CHLORIDE PACKAGE 80GM & 120 G by Computer Dialysis Systems, Inc. — Product Code LIF

K850127 is an FDA 510(k) premarket notification submitted by Computer Dialysis Systems, Inc. for the device "FORMA-TAG USP SODIUM CHLORIDE PACKAGE 80GM & 120 G". The FDA issued a decision of Substantially Equivalent on March 20, 1985. The device falls under product code LIF (Dialyzer Reprocessing System), a Class II device regulated under 21 CFR 876.5820. Computer Dialysis Systems, Inc. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 20, 1985
Date Received
January 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 Computer Dialysis Systems, Inc.

  • K831132 — COMPUDIAL/KP-1 (August 8, 1983)
  • K820575 — J.E.T. DIALYSIS SYSTEM (May 20, 1982)
  • K813107 — COMPUDIAL/KP-1 (March 23, 1982)

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