Siemens healthcare diagnostics inc.Filed the initial mdr 9610806-2017-00089 on august 11, 2017.November 15, 2017 corrected data: the pathromtin® sl reagent (catalog number 10484200), that was identified in the initial mdr is not registered in the united states (u.S.).The pma/510k number, k955450, which was listed corresponds to the u.S.Specific reagents.The pathromtin® sl reagents registered for use in the u.S.Have catalog numbers 10446066 and 10446067, pma/510k number k955450, and a unique device identifier (udi) number (b)(4).
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