Cleared Traditional

XYLENE SUBSTITUTE MONTANT

K854083 · Lerner Laboratories, Inc. · Pathology
Oct 1985
Decision
15d
Days
Class 1
Risk

About This 510(k) Submission

K854083 is an FDA 510(k) clearance for the XYLENE SUBSTITUTE MONTANT, 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, 15 days after receiving the submission on October 7, 1985. This device falls under the Pathology review panel. Regulated under 21 CFR 864.4010.

Submission Details

510(k) Number K854083 FDA.gov
FDA Decision Cleared SESE
Date Received October 07, 1985
Decision Date October 22, 1985
Days to Decision 15 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