IKAROS

Analyzer, Chromosome, Automated

METASYSTEMS GMBH

The following data is part of a premarket notification filed by Metasystems Gmbh with the FDA for Ikaros.

Pre-market Notification Details

• Device ID: K940240
• 510k Number: K940240
• Device Name: IKAROS
• Classification: Analyzer, Chromosome, Automated
• Applicant: METASYSTEMS GMBH HARDTSTRASSE 49 D-69207 SANDHAUSEN Germany, DE
• Contact: Andreas Plesch
• Correspondent: Andreas Plesch; METASYSTEMS GMBH HARDTSTRASSE 49 D-69207 SANDHAUSEN Germany, DE
• Product Code: LNJ
• CFR Regulation Number: 864.5260 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1994-01-19
• Decision Date: 1995-02-24

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
04250406400003	K940240	000