Cleared Traditional

DECALCIFIER SOLUTION

K842726 · E K Ind., Inc. · Pathology
Aug 1984
Decision
21d
Days
Class 1
Risk

About This 510(k) Submission

K842726 is an FDA 510(k) clearance for the DECALCIFIER SOLUTION, a Solution, Decalcifier, Acid Containing (Class I — General Controls, product code KDX), submitted by E K Ind., Inc. (Mchenry, US). The FDA issued a Cleared decision on August 3, 1984, 21 days after receiving the submission on July 13, 1984. This device falls under the Pathology review panel. Regulated under 21 CFR 864.4010.

Submission Details

510(k) Number K842726 FDA.gov
FDA Decision Cleared SESE
Date Received July 13, 1984
Decision Date August 03, 1984
Days to Decision 21 days
Submission Type Traditional
Review Panel Pathology (PA)
Summary —

Device Classification

Product Code KDX — Solution, Decalcifier, Acid Containing
Device Class Class I — General Controls
CFR Regulation 21 CFR 864.4010

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