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U.S. Department of Health and Human Services

Device Classification Under Section 513(f)(2)(De Novo)
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Device Classification Name early growth response gene 1 (egr1) fish probe kit for specimen characterization
De Novo Number DEN130010
510(K) Number K123951
Device Name VYSIS EGR1 FISH PROBE KIT - SC (SPECIMEN CHARACTERIZATION)
Requester
abbott molecular, inc.
1300 east touhy avenue
des plaines,  IL  60018
Contact nancy w bengtson
Regulation Number864.1870
Classification Product Code
PDO  
Date Received04/09/2013
Decision Date 07/29/2013
Decision granted (DENG)
Classification Advisory Committee Hematology
Review Advisory Committee Pathology
Classification Order Classification Order
FDA Review Decision Summary
Type Post-NSE
Predetermined Change
Control Plan Authorized		 No
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