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510(k) K830843

BLOOD GAS SOLUTIONS & CO-OXIMETER SOLU- by Rna Medical Corp. — Product Code JKT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 28, 1983
Date Received
March 17, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Gas Chromatograph, Carbon-Monoxide
Device Class
Class I
Regulation Number
862.3220
Review Panel
TX
Submission Type

Other clearances by Rna Medical Corp.

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  • K844589 — OSMOLARITY STANDARDS (March 1, 1985)
  • K842131 — FORMACLEAR- & MULTIPLE (September 10, 1984)
  • K842519 — BLOOD GAS FLUSH SOL. & FLUSH AGENT 1302 (August 17, 1984)
  • K813447 — SOLUTIONS & BUFFERS FOR BLOOD GAS INSTR (December 31, 1981)

Other clearances for product code JKT

  • K823535 — DILUENT, ZEROING SOLUTION & CO-OX/ISE (January 28, 1983)