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510(k) K800587

NSI WASH SOLUTION CONCENTRATE by Nobel Scientific Industries, Inc. — Product Code JJC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 8, 1980
Date Received
March 17, 1980
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Analyzer, Chemistry (Sequential Multiple, Continuous Flow) Clinical Use
Device Class
Class I
Regulation Number
862.2150
Review Panel
CH
Submission Type

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  • K854718 — NSI ASTRA TM ALBUMIN REAGENT KIT NSI ITEM # 7926 (December 19, 1985)
  • K850944 — NSI LYSING-D REAGENT -4000 ML (March 29, 1985)
  • K844782 — NSI ELT-D DILUTING FLUID 4000ML (March 5, 1985)
  • K823283 — FLUSHING SOLUTION (December 3, 1982)
  • K812866 — ASTRA REAGENT CONCENTRATE SYSTEM (December 17, 1981)
  • K810550 — SILVER ANODE (April 8, 1981)
  • K810549 — THERMAL PRINTER PAPER (April 8, 1981)
  • K802518 — BUN REAGENT ASTRA 4 & 8 ANALYZERS (November 12, 1980)

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