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510(k) K043268

SODIUM TEST KIT AND ELETROLYTE CAL 1 AND 2 by Randox Laboratories, Ltd. — Product Code CEI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 15, 2005
Date Received
November 26, 2004
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Uranyl Acetate/Zinc Acetate, Sodium
Device Class
Class II
Regulation Number
862.1665
Review Panel
CH
Submission Type

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Other clearances for product code CEI

  • K914039 — SODIUM REAGENT SET (October 31, 1991)
  • K902572 — SODIUM REAGENT SET (July 10, 1990)
  • K832552 — SODIUM TEST KIT (September 20, 1983)