Cleared Traditional

NSI ASTRA TM TOTAL PROTEIN REAGENT KIT, NSI #7928

K854717 · Nobel Scientific Industries, Inc. · Chemistry
Jan 1986
Decision
53d
Days
Class 2
Risk

About This 510(k) Submission

K854717 is an FDA 510(k) clearance for the NSI ASTRA TM TOTAL PROTEIN REAGENT KIT, NSI #7928, a Biuret (colorimetric), Total Protein (Class II — Special Controls, product code CEK), submitted by Nobel Scientific Industries, Inc. (Alexandria, US). The FDA issued a Cleared decision on January 14, 1986, 53 days after receiving the submission on November 22, 1985. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1635.

Submission Details

510(k) Number K854717 FDA.gov
FDA Decision Cleared SESE
Date Received November 22, 1985
Decision Date January 14, 1986
Days to Decision 53 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary —

Device Classification

Product Code CEK — Biuret (colorimetric), Total Protein
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1635

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