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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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11 to 20 of 64 Results
productcode LOM PMA Number p Decision Date From 1/1/2023 Decision Date To 1/1/2024
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Device
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PMA
Number
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ARCHITECT HBsAg Qualitative / HBsAg Qualitative Co... Abbott Laboratories P110029 S042 10/11/2023
ARCHITECT HBsAg Qualitative/HBsAg Qualitative Conf... Abbott Laboratories P110029 S043 06/23/2023
ARCHITECT HBsAg Qualitative, HBsAg Qualitative Con... Abbott Laboratories P110029 S044 06/22/2023
ARCHITECT HBsAg Qualitative/ Qualitative Confirmat... Abbott Laboratories P110029 S045 07/10/2023
Alinity i HBsAg Qualitative II Reagent Kit (2x100 ... Abbott Laboratories P110029 S046 11/03/2023
Alinity i HBsAg Qualitative II Reagent Kit (2x l 0... Abbott Laboratories P110029 S047 11/06/2023
ARCHITECT HBsAg Qualitative/Confirmatory, Alinity ... Abbott Laboratories P110029 S048 12/07/2023
ARCHITECT HBsAg Qualitative / Alinity i HBsAg Qual... Abbott Laboratories P110029 S049 12/14/2023
ARCHITECT HBsAg Next Qualitative and ARCHITECT HBs... Abbott Laboratories P210003 S004 05/08/2023
Alinity i HBsAg Next Qualitative assay, Alinity i ... Abbott Laboratories P210003 S006 09/28/2023
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