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510(k) K860297

HEMODIALYSIS CONCENTRATE FORMULATIONS/ADDITIVES by Renal Hygienics — Product Code FKQ

K860297 is an FDA 510(k) premarket notification submitted by Renal Hygienics for the device "HEMODIALYSIS CONCENTRATE FORMULATIONS/ADDITIVES". The FDA issued a decision of Substantially Equivalent on March 4, 1986. The device falls under product code FKQ (System, Dialysate Delivery, Central Multiple Patient), a Class II device regulated under 21 CFR 876.5820.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 4, 1986
Date Received
January 28, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Dialysate Delivery, Central Multiple Patient
Device Class
Class II
Regulation Number
876.5820
Review Panel
GU
Submission Type

Other clearances for product code FKQ

  • K052764 — DIACAP ULTRA DIALYSIS FLUID FILTER (June 9, 2006)
  • K893612 — TWO TANK DISSOLUTION MODULE (July 24, 1989)
  • K874084 — MULTIPLE ARTIFICIAL KIDNEY SYSTEMS (MAKS) #IDM (April 27, 1988)
  • K873421 — KAWASUMI A.V. FISTULA SET (October 9, 1987)
  • K870889 — ACID FUCHSIN SOLUTIONS (July 8, 1987)
  • K861730 — ACTRIL FOR KIDNEY MACHINE DISINFECTANT (June 9, 1987)
  • K864635 — FOUR TANK DISSOLUTION MODULE (January 13, 1987)
  • K862304 — DRAKE WILLOCK CENTRAL DIALYSATE DELIVERY SYSTEM (September 9, 1986)
  • K861472 — MAKS CENTRAL DELIVERY SYSTEMS MODELS 11-425/11-445 (July 10, 1986)
  • K852359 — AMUCHINA/DIALYZER DISINFECTANT (May 13, 1986)

FDA data resources