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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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ARCHITECT CORE-M (LN 6l23), Calibrators, Controls ... Abbott Laboratories P060035 S027 11/20/2018
ARCHITECT CORE, LN 6L22 Abbott Laboratories P080023 S029 08/09/2018
ARCHITECT CORE (LN 6L22) Abbott Laboratories P080023 S030 11/09/2018
ARCHITECT HBsAG Qualitative Reagent Kit (100/500 T... Abbott Laboratories P110029 S027 07/18/2018
ARCHITECT HBsAg Qualitative (LN 4P53) and HBsAg Qu... Abbott Laboratories P110029 S028 11/14/2018
ARCHITECT AUSAB (LN 1L82) ABBOTT LABORATORIES INC P050051 S034 11/14/2018
ETI-MAK-2 PLUS and HBsAg Confirmatory Test Assays DIASORIN, INC. P990038 S025 03/14/2018
ETI-MAK-2 PLUS and HBsAg Confirmatory Test Assays DIASORIN, INC. P990038 S027 04/24/2018
ETI-MAK-2 PLUS, HBsAg Confirmatory Test Assays DIASORIN, INC. P990038 S028 06/28/2018
ETI-AB-AUK PLUS Assay DIASORIN, INC. P990042 S021 03/14/2018
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