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510(k) K851362

STANDARD SOLUTION OF CONDUCTIVITY & MEASUREMENT OF by Rna Medical Corp. — Product Code FKH

K851362 is an FDA 510(k) premarket notification submitted by Rna Medical Corp. for the device "STANDARD SOLUTION OF CONDUCTIVITY & MEASUREMENT OF". The FDA issued a decision of Substantially Equivalent on June 12, 1985. The device falls under product code FKH (Solution-Test Standard-Conductivity, Dialysis), a Class II device regulated under 21 CFR 876.5820. Rna Medical Corp. has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 12, 1985
Date Received
April 4, 1985
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 Rna Medical Corp.

  • K844589 — OSMOLARITY STANDARDS (March 1, 1985)
  • K842131 — FORMACLEAR- & MULTIPLE (September 10, 1984)
  • 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 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)
  • K863824 — SOLUTION/TEST STANDARD/CONDUCT. DIALY.&MULT.SOLUT. (October 24, 1986)
  • K812622 — HEMODIALYSIS VENOUS & ARTERIAL SET (September 24, 1981)

FDA data resources