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510(k) K854718

NSI ASTRA TM ALBUMIN REAGENT KIT NSI ITEM # 7926 by Nobel Scientific Industries, Inc. — Product Code CIX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 19, 1985
Date Received
November 22, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Bromcresol Green Dye-Binding, Albumin
Device Class
Class II
Regulation Number
862.1035
Review Panel
CH
Submission Type

Other clearances by Nobel Scientific Industries, Inc.

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  • 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)
  • K810549 — THERMAL PRINTER PAPER (April 8, 1981)
  • K810550 — SILVER ANODE (April 8, 1981)
  • K802518 — BUN REAGENT ASTRA 4 & 8 ANALYZERS (November 12, 1980)
  • K801346 — NSI REAGENT SYSTEM FOR ORTHO ELT-8 HEMA (August 12, 1980)

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