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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Chronic Lymphocytic Leukemia Fish Probe Kit
510(k) Number K962873
Device Name CEP 12 SPECTRUMORANGE DIRECT LABELED CHROMOSOME ENUMERATION DNA PROBE
Applicant
Vysis
3100 Woodcreek Dr.
Downers Grove,  IL  60515
Applicant Contact RUSSEL K ENNS
Correspondent
Vysis
3100 Woodcreek Dr.
Downers Grove,  IL  60515
Correspondent Contact RUSSEL K ENNS
Regulation Number866.6040
Classification Product Code
OVQ  
Subsequent Product Code
KIR  
Date Received07/23/1996
Decision Date 01/13/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Pathology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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