Cleared Traditional

NSI ASTRA TM ALBUMIN REAGENT KIT NSI ITEM # 7926

K854718 · Nobel Scientific Industries, Inc. · Chemistry
Dec 1985
Decision
27d
Days
Class 2
Risk

About This 510(k) Submission

K854718 is an FDA 510(k) clearance for the NSI ASTRA TM ALBUMIN REAGENT KIT NSI ITEM # 7926, a Bromcresol Green Dye-binding, Albumin (Class II — Special Controls, product code CIX), submitted by Nobel Scientific Industries, Inc. (Alexandria, US). The FDA issued a Cleared decision on December 19, 1985, 27 days after receiving the submission on November 22, 1985. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1035.

Submission Details

510(k) Number K854718 FDA.gov
FDA Decision Cleared SESE
Date Received November 22, 1985
Decision Date December 19, 1985
Days to Decision 27 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary —

Device Classification

Product Code CIX — Bromcresol Green Dye-binding, Albumin
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1035

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