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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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1 to 10 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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VITROS Immunodiagnostic Products Anti-HBs Quantita... Ortho-Clinical Diagnostics, In P000014 S034 12/17/2018
VITROS Immunodiagnostic Products HBsAg Reagent Pac... Ortho-Clinical Diagnostics, In P000044 S039 12/17/2018
VITROS Immunodiagnostic Products Anti-HBc Reagent ... ORTHO-CLINICAL DIAGNOSTICS P030024 S028 12/17/2018
VITROS Immunodiagnostic Products Anti-HBc IgM Reag... Ortho-Clinical Diagnostics, In P030026 S035 12/17/2018
VITROS Immunodiagnostic Products HBeAg Reagent Pac... Ortho-Clinical Diagnostics, In P090028 S016 12/17/2018
VITROS Immunodiagnostic Products Anti-HBe Reagent ... ORTHO-CLINICAL DIAGNOSTICS P100001 S015 12/17/2018
ARCHITECT CORE-M (LN 6l23), Calibrators, Controls ... Abbott Laboratories P060035 S027 11/20/2018
ARCHITECT AUSAB (LN 1L82) ABBOTT LABORATORIES INC P050051 S034 11/14/2018
ARCHITECT HBsAg Qualitative (LN 4P53) and HBsAg Qu... Abbott Laboratories P110029 S028 11/14/2018
ARCHITECT CORE (LN 6L22) Abbott Laboratories P080023 S030 11/09/2018
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