Cleared Traditional

FORMICAL

K821443 · Lerner Laboratories, Inc. · Chemistry
Jun 1982
Decision
19d
Days
Class 1
Risk

About This 510(k) Submission

K821443 is an FDA 510(k) clearance for the FORMICAL, a Solution, Decalcifier, Acid Containing (Class I — General Controls, product code KDX), submitted by Lerner Laboratories, Inc. (Mchenry, US). The FDA issued a Cleared decision on June 2, 1982, 19 days after receiving the submission on May 14, 1982. This device falls under the Chemistry review panel. Regulated under 21 CFR 864.4010.

Submission Details

510(k) Number K821443 FDA.gov
FDA Decision Cleared SESE
Date Received May 14, 1982
Decision Date June 02, 1982
Days to Decision 19 days
Submission Type Traditional
Review Panel Chemistry (CH)
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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