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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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11 to 20 of 46 Results
productcode LOM PMA Number p Decision Date From 1/1/2016 Decision Date To 1/1/2017
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ELECSYS HBEAG ROCHE DIAGNOSTICS OPERATIONS I P130015 S008 11/22/2016
ELECSYS ANTI-HBS IMMUNOASSAY ROCHE DIAGNOSTICS CORP. P010054 S026 08/08/2016
ELECSYS ANTI-HBS TEST SYSTEM ROCHE DIAGNOSTICS CORP. P010054 S027 02/24/2016
ELECSYS ANTI-HBS ROCHE DIAGNOSTICS CORP. P010054 S028 03/16/2016
ELECSYS ANTI-HBS ROCHE DIAGNOSTICS CORP. P010054 S029 11/22/2016
Elecsys Anti-HBc II, PreciControl Anti-HBc ROCHE DIAGNOSTICS CORP. P100031 S014 08/08/2016
ELECSYS ANTI-HBC TEST SYSTEM ROCHE DIAGNOSTICS CORP. P100031 S015 02/24/2016
ELECSYS ANTI-HBC IMMUNOASSAY & ELECSYS PRECICONTRO... ROCHE DIAGNOSTICS CORP. P100031 S016 03/16/2016
ELECSYS ANTI-HBC IMMUNOASSAY ROCHE DIAGNOSTICS CORP. P100032 S011 08/08/2016
ELECSYS ANTI-HBC TEST SYSTEM ROCHE DIAGNOSTICS CORP. P100032 S012 02/24/2016
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