Cleared Traditional

NSI ELT-D DILUTING FLUID 4000ML

K844782 · Nobel Scientific Industries, Inc. · Hematology
Mar 1985
Decision
85d
Days
Class 1
Risk

About This 510(k) Submission

K844782 is an FDA 510(k) clearance for the NSI ELT-D DILUTING FLUID 4000ML, a Diluent, Blood Cell (Class I — General Controls, product code GIF), submitted by Nobel Scientific Industries, Inc. (Alexandria, US). The FDA issued a Cleared decision on March 5, 1985, 85 days after receiving the submission on December 10, 1984. This device falls under the Hematology review panel. Regulated under 21 CFR 864.8200.

Submission Details

510(k) Number K844782 FDA.gov
FDA Decision Cleared SESE
Date Received December 10, 1984
Decision Date March 05, 1985
Days to Decision 85 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary —

Device Classification

Product Code GIF — Diluent, Blood Cell
Device Class Class I — General Controls
CFR Regulation 21 CFR 864.8200

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