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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Early Growth Response 1 (Egr) Fish Probe Kit
510(k) Number K091960
Device Name VYSIS EGR1 FISH PROBE KIT (VYSIS LSI EGR1 SPECTRUM/ORANGE/D5S23, D5S721, SPECTRUM GREEN PROBE), MODEL 4N37-020
Applicant
ABBOTT MOLECULAR, INC.
1300 EAST TOUHY AVENUE
DES PLAINES,  IL  60018
Applicant Contact PAMELA L SWATKOWSKI
Correspondent
ABBOTT MOLECULAR, INC.
1300 EAST TOUHY AVENUE
DES PLAINES,  IL  60018
Correspondent Contact PAMELA L SWATKOWSKI
Regulation Number866.6040
Classification Product Code
OWK  
Date Received07/01/2009
Decision Date 08/29/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Pathology
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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