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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Applicant ROCHE DIAGNOSTICS CORP. productcode LTJ Decision Date To 05/17/2024
 
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PMA
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ELECSYS FREE PSA IMMUNOASSAY/CALSET/CALCHECK ROCHE DIAGNOSTICS CORP. P000027 12/12/2000
ELSECSYS FREE PSA IMMUNOASSAY,FREE PSA CALSET,FREE... ROCHE DIAGNOSTICS CORP. P000027 S001 04/29/2002
ELECSYS FREE PSA IMMUNOASSAY/CALSET/CALCHEK ROCHE DIAGNOSTICS CORP. P000027 S002 02/24/2003
ELECSYS FREE PSA IMMUNOASSAY/CALSET/CALCHECK ROCHE DIAGNOSTICS CORP. P000027 S022 03/16/2016
Elecsys free PSA, free PSA Calset, free PSA CalChe... ROCHE DIAGNOSTICS CORP. P000027 S023 03/02/2017
Elecsys free PSA Immunoassay ROCHE DIAGNOSTICS CORP. P000027 S025 06/23/2017
Elecsys Free PSA Immunoassay ROCHE DIAGNOSTICS CORP. P000027 S026 08/31/2017
Elecsys free PSA ROCHE DIAGNOSTICS CORP. P000027 S028 12/20/2017
Elecsys free PSA ROCHE DIAGNOSTICS CORP. P000027 S030 04/20/2018
Elecsys free PSA ROCHE DIAGNOSTICS CORP. P000027 S031 06/13/2018
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