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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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1 to 10 of 24 Results
productcode PQP PMA Number p Decision Date From 1/1/2020 Decision Date To 1/1/2021
 
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PMA
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Praxis Extended RAS Panel Illumina, Inc. P160038 S018 12/04/2020
Oncomine Dx Target Test LIFE TECHNOLOGIES CORPORATION P160045 S024 12/01/2020
Oncomine Dx Target Test LIFE TECHNOLOGIES CORPORATION P160045 S023 11/11/2020
FoundationOne Liquid CDx Foundation Medicine, Inc. P200016 11/06/2020
FoundationOne Liquid CDx (F1 Liquid CDx) Foundation Medicine, Inc. P200006 10/26/2020
Oncomine Dx Target Test LIFE TECHNOLOGIES CORPORATION P160045 S021 10/23/2020
FoundationOne CDx (F1CDx) Foundation Medicine, Inc. P170019 S017 10/23/2020
FoundationOne CDx Foundation Medicine, Inc. P170019 S020 10/15/2020
Oncomine Dx Target Test LIFE TECHNOLOGIES CORPORATION P160045 S022 10/08/2020
Praxis Extended RAS Panel Illumina, Inc. P160038 S017 09/02/2020
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