Home / 510(k) Clearances / K842131

510(k) K842131

FORMACLEAR- & MULTIPLE by Rna Medical Corp. — Product Code FKQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 10, 1984
Date Received
May 30, 1984
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 by Rna Medical Corp.

  • K851362 — STANDARD SOLUTION OF CONDUCTIVITY & MEASUREMENT OF (June 12, 1985)
  • K844589 — OSMOLARITY STANDARDS (March 1, 1985)
  • K842519 — BLOOD GAS FLUSH SOL. & FLUSH AGENT 1302 (August 17, 1984)
  • K830843 — BLOOD GAS SOLUTIONS & CO-OXIMETER SOLU- (April 28, 1983)
  • K813447 — SOLUTIONS & BUFFERS FOR BLOOD GAS INSTR (December 31, 1981)

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)