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510(k) K905217

FORMASURE TEST REAGENT by Di-Chem, Inc. — Product Code LIF

K905217 is an FDA 510(k) premarket notification submitted by Di-Chem, Inc. for the device "FORMASURE TEST REAGENT". The FDA issued a decision of Substantially Equivalent on April 9, 1991. The device falls under product code LIF (Dialyzer Reprocessing System), a Class II device regulated under 21 CFR 876.5820. Di-Chem, Inc. has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 9, 1991
Date Received
November 20, 1990
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 Di-Chem, Inc.

  • K202508 — Hemo-Lyte C Cartridge (August 12, 2022)
  • K171015 — Citryte (October 13, 2017)
  • K012547 — HEMO-LYTE HEMODIALYSIS GRADE SODIUM BICARBONATE SOLUTION (January 18, 2002)
  • K012328 — HEMO-LYTE HEMODIALYSIS GRADE SODIUM BICARBONATE POWDER (January 18, 2002)
  • K823103 — DIALYSATE ADDITIVES-POWDER/LIQUID (November 17, 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