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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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1 to 10 of 46 Results
productcode LOM PMA Number p Decision Date From 1/1/2010 Decision Date To 1/1/2011
 
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Device
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PMA
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ELECSYS ANTI-HBS TEST SYSTEM ROCHE DIAGNOSTICS CORP. P010054 S011 01/07/2010
VITROS IMMUNDIAGNOSTICS PRODUCTS ANTI-HBS REAGENT ... Ortho-Clinical Diagnostics, In P000014 S019 01/11/2010
ETI-MAK-2 PLUS ASSAY DIASORIN, INC. P990038 S012 01/12/2010
ETI-AB-EBK PLUS ASSAY DIASORIN, INC. P990041 S011 01/12/2010
ETI-EBK PLUS ASSAY DIASORIN, INC. P990043 S012 01/12/2010
ETI-CORE-IGMK PLUS ASSAY DIASORIN, INC. P990044 S009 01/12/2010
ETI-AB-COREK PLUS ASSAY DIASORIN, INC. P990045 S009 01/12/2010
IMMULITE/IMMULITE 1000 & IMMULITE 2000 HBSAG & IMM... Siemens Healthcare Diagnostics P010050 S010 01/20/2010
IMMULITE/IMMULITE 1000 & IMMULITE 2000 ANTI-HBC Siemens Healthcare Diagnostics P010051 S007 01/20/2010
IMMULITE/IMMULITE 1000 & IMMULITE 2000 ANTI-HBS Siemens Healthcare Diagnostics P010052 S007 01/20/2010
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