Cleared Traditional

MEGACOLOR

K860319 · Cytocolor, Inc. · Pathology
Feb 1986
Decision
23d
Days
Class 1
Risk

About This 510(k) Submission

K860319 is an FDA 510(k) clearance for the MEGACOLOR, a Stains, Chemical Solution (Class I — General Controls, product code LED), submitted by Cytocolor, Inc. (Hinckley, US). The FDA issued a Cleared decision on February 20, 1986, 23 days after receiving the submission on January 28, 1986. This device falls under the Pathology review panel. Regulated under 21 CFR 864.1850.

Submission Details

510(k) Number K860319 FDA.gov
FDA Decision Cleared SESE
Date Received January 28, 1986
Decision Date February 20, 1986
Days to Decision 23 days
Submission Type Traditional
Review Panel Pathology (PA)
Summary —

Device Classification

Product Code LED — Stains, Chemical Solution
Device Class Class I — General Controls
CFR Regulation 21 CFR 864.1850