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510(k) K863824

SOLUTION/TEST STANDARD/CONDUCT. DIALY.&MULT.SOLUT. by D.R.G. Scientific Industries — Product Code FKH

K863824 is an FDA 510(k) premarket notification submitted by D.R.G. Scientific Industries for the device "SOLUTION/TEST STANDARD/CONDUCT. DIALY.&MULT.SOLUT.". The FDA issued a decision of Substantially Equivalent on October 24, 1986. The device falls under product code FKH (Solution-Test Standard-Conductivity, Dialysis), a Class II device regulated under 21 CFR 876.5820. D.R.G. Scientific Industries has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 24, 1986
Date Received
September 30, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Solution-Test Standard-Conductivity, Dialysis
Device Class
Class II
Regulation Number
876.5820
Review Panel
GU
Submission Type

Other clearances by D.R.G. Scientific Industries

  • K892329 — OSMOMETER STANDARD SOLUTIONS (October 31, 1989)
  • K870889 — ACID FUCHSIN SOLUTIONS (July 8, 1987)
  • K863880 — BLOOD GASES/ PO2, PCO2 AND BLOOD PH ANALYSIS PROD. (November 24, 1986)
  • K863825 — CO-OXIMETER SOLUTIONS (November 24, 1986)

Other clearances for product code FKH

  • K191496 — TDS Standard Solution (August 5, 2019)
  • K130100 — COMINED STANDARD SOLUTION (April 18, 2013)
  • K041636 — H&S-CONDUCTIVITY STANDARD SOLUTION (July 2, 2004)
  • K033330 — CONDUCTIVITY/TDS CALIBRATOR SOLUTION (February 27, 2004)
  • K032075 — CONDUCTIVITY STANDARD SOLUTION-METERCARE (September 17, 2003)
  • K851362 — STANDARD SOLUTION OF CONDUCTIVITY & MEASUREMENT OF (June 12, 1985)
  • K812622 — HEMODIALYSIS VENOUS & ARTERIAL SET (September 24, 1981)

FDA data resources