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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
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