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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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61 to 70 of 73 Results
productcode LOM PMA Number p Decision Date From 1/1/2018 Decision Date To 1/1/2019
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PMA
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Elecsys Anti-HBc II ROCHE DIAGNOSTICS CORP. P100032 S018 04/20/2018
Elecsys Anti-HBc IgM ROCHE DIAGNOSTICS CORP. P110031 S022 04/20/2018
Elecsys HBsAg Immunoassay ROCHE DIAGNOSTICS CORP. P990012 S031 04/20/2018
ADVIA Centaur HBsAgII (HBsII), ADVIA Centaur HBsAg... SIEMENS CORP. P110041 S004 04/19/2018
ETI-MAK-2 PLUS and HBsAg Confirmatory Test Assays DIASORIN, INC. P990038 S025 03/14/2018
ETI-AB-AUK PLUS Assay DIASORIN, INC. P990042 S021 03/14/2018
ETI-EBK PLUS Assay DIASORIN, INC. P990043 S025 03/14/2018
Elecsys HBeAg and PreciControl HBeAg ROCHE DIAGNOSTICS OPERATIONS I P130015 S013 03/02/2018
VITROS Immunodiagnostic Products Anti-HBc IgM Reag... Ortho-Clinical Diagnostics, In P030026 S033 02/23/2018
HBeAg Reagent Pack and Calibrator Ortho-Clinical Diagnostics, In P090028 S014 02/16/2018
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