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510(k) K844589

OSMOLARITY STANDARDS by Rna Medical Corp. — Product Code JMZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 1, 1985
Date Received
November 26, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Comparison Of Freezing Points & Stds. Of Known Osmotic Pressure, Osmolality
Device Class
Class I
Regulation Number
862.1540
Review Panel
CH
Submission Type

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  • 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 JMZ

  • K843680 — URI-VAL (March 29, 1985)