Cleared Traditional

XYLENE SUBSTITUTE

K853694 · Lerner Laboratories, Inc. · Pathology
Oct 1985
Decision
48d
Days
Class 1
Risk

About This 510(k) Submission

K853694 is an FDA 510(k) clearance for the XYLENE SUBSTITUTE, a Agent, Clearing (Class I — General Controls, product code KEM), submitted by Lerner Laboratories, Inc. (New Haven, US). The FDA issued a Cleared decision on October 22, 1985, 48 days after receiving the submission on September 4, 1985. This device falls under the Pathology review panel. Regulated under 21 CFR 864.4010.

Submission Details

510(k) Number K853694 FDA.gov
FDA Decision Cleared SESE
Date Received September 04, 1985
Decision Date October 22, 1985
Days to Decision 48 days
Submission Type Traditional
Review Panel Pathology (PA)
Summary —

Device Classification

Product Code KEM — Agent, Clearing
Device Class Class I — General Controls
CFR Regulation 21 CFR 864.4010