Cleared Traditional

IKAROS

K940240 · Metasystems GmbH · Pathology
Feb 1995
Decision
401d
Days
Class 2
Risk

About This 510(k) Submission

K940240 is an FDA 510(k) clearance for the IKAROS, a Analyzer, Chromosome, Automated (Class II — Special Controls, product code LNJ), submitted by Metasystems GmbH (Germany, DE). The FDA issued a Cleared decision on February 24, 1995, 401 days after receiving the submission on January 19, 1994. This device falls under the Pathology review panel. Regulated under 21 CFR 864.5260.

Submission Details

510(k) Number K940240 FDA.gov
FDA Decision Cleared SESE
Date Received January 19, 1994
Decision Date February 24, 1995
Days to Decision 401 days
Submission Type Traditional
Review Panel Pathology (PA)
Summary Summary PDF

Device Classification

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