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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 K902311
Device Name GENEVISION - COMPUTER ASSISTED CHROMOSOME KARYO.
Applicant
Applied Imaging Corp.
2340a Walsh Ave.
Santa Clara,  CA  95051
Applicant Contact STEPHEN M RUDY
Correspondent
Applied Imaging Corp.
2340a Walsh Ave.
Santa Clara,  CA  95051
Correspondent Contact STEPHEN M RUDY
Regulation Number864.5260
Classification Product Code
LNJ  
Date Received05/23/1990
Decision Date 08/20/1990
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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