FDA 510(k) Application Details - K170065

Device Classification Name	Enzymatic Method, Bilirubin   More FDA Info for this Device
510(K) Number	K170065
Device Name	Enzymatic Method, Bilirubin
Applicant	Siemens Healthcare Diagnostics, Inc. 511 Benedict Avenue Tarrytown, NY 10591 US Other 510(k) Applications for this Company
Contact	Julie Warren Other 510(k) Applications for this Contact
Regulation Number	862.1110   More FDA Info for this Regulation Number
Classification Product Code	JFM Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/09/2017
Decision Date	03/09/2017
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CH - Clinical Chemistry
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
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