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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name dna-probe kit, human chromosome
510(k) Number K953591
Device Name CEP 8 SPECTRUMORANGE DNA PROBE KIT
Applicant
VYSIS
3100 WOODCREEK DR.
downers grove,  IL  60515
Applicant Contact russell k enns
Correspondent
VYSIS
3100 WOODCREEK DR.
downers grove,  IL  60515
Correspondent Contact russell k enns
Regulation Number866.4700
Classification Product Code
OYU  
Subsequent Product Code
KIR  
Date Received08/01/1995
Decision Date 11/29/1996
Decision substantially equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Pathology
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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