Cleared Traditional

AKS II

K895095 · Amoco Technology Co. · Pathology
Feb 1990
Decision
179d
Days
Class 2
Risk

About This 510(k) Submission

K895095 is an FDA 510(k) clearance for the AKS II, a Analyzer, Chromosome, Automated (Class II — Special Controls, product code LNJ), submitted by Amoco Technology Co. (Naperville, US). The FDA issued a Cleared decision on February 9, 1990, 179 days after receiving the submission on August 14, 1989. This device falls under the Pathology review panel. Regulated under 21 CFR 864.5260.

Submission Details

510(k) Number K895095 FDA.gov
FDA Decision Cleared SESE
Date Received August 14, 1989
Decision Date February 09, 1990
Days to Decision 179 days
Submission Type Traditional
Review Panel Pathology (PA)
Summary —

Device Classification

Product Code LNJ — Analyzer, Chromosome, Automated
Device Class Class II — Special Controls
CFR Regulation 21 CFR 864.5260