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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Analyzer, Chromosome, Automated
510(k) Number K940240
Device Name IKAROS
Applicant
Metasystems GmbH
Hardtstrasse 49
D-69207 Sandhausen
Germany,  DE
Applicant Contact ANDREAS PLESCH
Correspondent
Metasystems GmbH
Hardtstrasse 49
D-69207 Sandhausen
Germany,  DE
Correspondent Contact ANDREAS PLESCH
Regulation Number864.5260
Classification Product Code
LNJ  
Date Received01/19/1994
Decision Date 02/24/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Pathology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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