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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
Contact pamela l swatkowski
Regulation Number866.6040
Classification Product Code
OWK  
Date Received07/02/2009
Decision Date 08/29/2011
Decision substantially equivalent - CLIA submission (CS)
Classification Advisory Committee Immunology
Review Advisory Committee Hematology
summary summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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