Cleared Traditional

ACETIC ACID, 3% V/V

K842936 · E K Ind., Inc. · Hematology
Sep 1984
Decision
49d
Days
Class 1
Risk

About This 510(k) Submission

K842936 is an FDA 510(k) clearance for the ACETIC ACID, 3% V/V, a Products, Red-cell Lysing Products (Class I — General Controls, product code GGK), submitted by E K Ind., Inc. (Mchenry, US). The FDA issued a Cleared decision on September 12, 1984, 49 days after receiving the submission on July 25, 1984. This device falls under the Hematology review panel. Regulated under 21 CFR 864.8540.

Submission Details

510(k) Number K842936 FDA.gov
FDA Decision Cleared SESE
Date Received July 25, 1984
Decision Date September 12, 1984
Days to Decision 49 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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