Cleared Traditional

ATS DOBELL & O'CONNOR'S IODINE

K890861 · Alpha-Tec Systems, Inc. · Pathology
Mar 1989
Decision
30d
Days
Class 1
Risk

About This 510(k) Submission

K890861 is an FDA 510(k) clearance for the ATS DOBELL & O'CONNOR'S IODINE, 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 March 23, 1989, 30 days after receiving the submission on February 21, 1989. This device falls under the Pathology review panel. Regulated under 21 CFR 864.1850.

Submission Details

510(k) Number K890861 FDA.gov
FDA Decision Cleared SESE
Date Received February 21, 1989
Decision Date March 23, 1989
Days to Decision 30 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