Cleared Traditional

NSI ASTRA TM CALCIUM REAGENT KIT NSI ITEM # 7909

K854716 · Nobel Scientific Industries, Inc. · Chemistry
Jan 1986
Decision
46d
Days
Class 2
Risk

About This 510(k) Submission

K854716 is an FDA 510(k) clearance for the NSI ASTRA TM CALCIUM REAGENT KIT NSI ITEM # 7909, a Cresolphthalein Complexone, Calcium (Class II — Special Controls, product code CIC), submitted by Nobel Scientific Industries, Inc. (Alexandria, US). The FDA issued a Cleared decision on January 7, 1986, 46 days after receiving the submission on November 22, 1985. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1145.

Submission Details

510(k) Number K854716 FDA.gov
FDA Decision Cleared SESE
Date Received November 22, 1985
Decision Date January 07, 1986
Days to Decision 46 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary —

Device Classification

Product Code CIC — Cresolphthalein Complexone, Calcium
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1145

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