FDA 510(k) Application Details - K121084

Device Classification Name	Single (Specified) Analyte Controls (Assayed And Unassayed)   More FDA Info for this Device
510(K) Number	K121084
Device Name	Single (Specified) Analyte Controls (Assayed And Unassayed)
Applicant	Siemens Healthcare Diagnostics Inc. PO BOX 6101 MAILSTOP 514 NEWARK, DE 19714-6101 US Other 510(k) Applications for this Company
Contact	FRANCES A DILLON Other 510(k) Applications for this Contact
Regulation Number	862.1660   More FDA Info for this Regulation Number
Classification Product Code	JJX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/10/2012
Decision Date	05/09/2012
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CH - Clinical Chemistry
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status	Summary
Type	Abbreviated
Reviewed By Third Party	N
Expedited Review