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510(k) K854716

NSI ASTRA TM CALCIUM REAGENT KIT NSI ITEM # 7909 by Nobel Scientific Industries, Inc. — Product Code CIC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 7, 1986
Date Received
November 22, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cresolphthalein Complexone, Calcium
Device Class
Class II
Regulation Number
862.1145
Review Panel
CH
Submission Type

Other clearances by Nobel Scientific Industries, Inc.

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  • 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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