Cleared Traditional

CLEARENE, CLEARING AGENT

K855109 · Surgipath Medical Industries, Inc. · Pathology
Jan 1986
Decision
15d
Days
Class 1
Risk

About This 510(k) Submission

K855109 is an FDA 510(k) clearance for the CLEARENE, CLEARING AGENT, a Agent, Clearing (Class I — General Controls, product code KEM), submitted by Surgipath Medical Industries, Inc. (Grayslake, US). The FDA issued a Cleared decision on January 7, 1986, 15 days after receiving the submission on December 23, 1985. This device falls under the Pathology review panel. Regulated under 21 CFR 864.4010.

Submission Details

510(k) Number K855109 FDA.gov
FDA Decision Cleared SESE
Date Received December 23, 1985
Decision Date January 07, 1986
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