Cleared Traditional

ATS LUGOL'S IODINE SOLUTION

K890020 · Alpha-Tec Systems, Inc. · Pathology
Feb 1989
Decision
51d
Days
Class 1
Risk

About This 510(k) Submission

K890020 is an FDA 510(k) clearance for the ATS LUGOL'S IODINE SOLUTION, a Stains, Microbiologic (Class I — General Controls, product code JTS), submitted by Alpha-Tec Systems, Inc. (Irvine, US). The FDA issued a Cleared decision on February 24, 1989, 51 days after receiving the submission on January 4, 1989. This device falls under the Pathology review panel. Regulated under 21 CFR 864.1850.

Submission Details

510(k) Number K890020 FDA.gov
FDA Decision Cleared SESE
Date Received January 04, 1989
Decision Date February 24, 1989
Days to Decision 51 days
Submission Type Traditional
Review Panel Pathology (PA)
Summary —

Device Classification

Product Code JTS — Stains, Microbiologic
Device Class Class I — General Controls
CFR Regulation 21 CFR 864.1850