Cleared Traditional

XYLENE

K881282 · Anatech, Ltd. · Pathology
Apr 1988
Decision
11d
Days
Class 1
Risk

About This 510(k) Submission

K881282 is an FDA 510(k) clearance for the XYLENE, a Agent, Clearing (Class I — General Controls, product code KEM), submitted by Anatech, Ltd. (Battle Creek, US). The FDA issued a Cleared decision on April 5, 1988, 11 days after receiving the submission on March 25, 1988. This device falls under the Pathology review panel. Regulated under 21 CFR 864.4010.

Submission Details

510(k) Number K881282 FDA.gov
FDA Decision Cleared SESE
Date Received March 25, 1988
Decision Date April 05, 1988
Days to Decision 11 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