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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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Decision Date To: 05/12/2024
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Device Name
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Requester
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De Novo
Number
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510(k)
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Decision
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LBA AFP-L3, AFP-L3 CALIBRATOR SET, AFP-L WAKO CHEMICALS, USA, INC. DEN050002 K041847 05/19/2005
PAXGENE BLOOD RNA SYSTEM PREANALYTIX GMBH DEN050003 K042613 04/18/2005
TAG-IT CYSTIC FIBROSIS KIT TM BIOSCIENCE CORPORATION DEN050004 K043011 05/09/2005
CARDIOMEMS ENDOSENSOR WITH DELIVERY SYST CARDIOMEMS INC DEN050006 K050939 10/28/2005
HEALTHCHECK(TM) HOME TEST FOR LOSS OF TH FMG INNOVATIONS, INC. DEN050007 K051653 03/27/2006
PHICAL TEST GENOVA DIAGNOSTICS DEN060001 K050007 04/26/2006
INRANGE REMOTE MEDICATION MANAGEMENT SYS INRANGE SYSTEMS, INC. DEN060002 K051338 06/13/2007
TEPHAFLEX ABSORBABLE SUTURE TEPHA, INC. DEN060003 K052225 02/08/2007
COMPUTERIZED LABOR MONITORING SYSTEM BARNEV, LTD. DEN060006 K060028 01/30/2007
INTROL CF PANEL I CONTROL MAINE MOLECULAR QUALITY CONTROLS, INC. DEN060007 K060070 10/12/2006
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