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FDA 510(k) Application Details - K140818
Device Classification Name
Single (Specified) Analyte Controls (Assayed And Unassayed)
More FDA Info for this Device
510(K) Number
K140818
Device Name
Single (Specified) Analyte Controls (Assayed And Unassayed)
Applicant
Siemens Healthcare Diagnostics Inc.
511 BENEDICT AVE.
TARRYTOWN, NY 10591 US
Other 510(k) Applications for this Company
Contact
Ernest Joseph
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
04/01/2014
Decision Date
05/01/2014
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
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