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510(k) K870889

ACID FUCHSIN SOLUTIONS by D.R.G. Scientific Industries — Product Code FKQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 8, 1987
Date Received
March 5, 1987
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 D.R.G. Scientific Industries

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  • K863880 — BLOOD GASES/ PO2, PCO2 AND BLOOD PH ANALYSIS PROD. (November 24, 1986)
  • K863825 — CO-OXIMETER SOLUTIONS (November 24, 1986)
  • K863824 — SOLUTION/TEST STANDARD/CONDUCT. DIALY.&MULT.SOLUT. (October 24, 1986)

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  • K874084 — MULTIPLE ARTIFICIAL KIDNEY SYSTEMS (MAKS) #IDM (April 27, 1988)
  • K873421 — KAWASUMI A.V. FISTULA SET (October 9, 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)
  • K860297 — HEMODIALYSIS CONCENTRATE FORMULATIONS/ADDITIVES (March 4, 1986)