Cleared Traditional

NSI LYSING-D REAGENT -4000 ML

K850944 · Nobel Scientific Industries, Inc. · Hematology
Mar 1985
Decision
22d
Days
Class 1
Risk

About This 510(k) Submission

K850944 is an FDA 510(k) clearance for the NSI LYSING-D REAGENT -4000 ML, a Products, Red-cell Lysing Products (Class I — General Controls, product code GGK), submitted by Nobel Scientific Industries, Inc. (Alexandria, US). The FDA issued a Cleared decision on March 29, 1985, 22 days after receiving the submission on March 7, 1985. This device falls under the Hematology review panel. Regulated under 21 CFR 864.8540.

Submission Details

510(k) Number K850944 FDA.gov
FDA Decision Cleared SESE
Date Received March 07, 1985
Decision Date March 29, 1985
Days to Decision 22 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary —

Device Classification

Product Code GGK — Products, Red-cell Lysing Products
Device Class Class I — General Controls
CFR Regulation 21 CFR 864.8540

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