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FDA 510(k) Application Details - K133816
Device Classification Name
Single (Specified) Analyte Controls (Assayed And Unassayed)
More FDA Info for this Device
510(K) Number
K133816
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
12/16/2013
Decision Date
06/24/2014
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CH - Clinical Chemistry
Review Advisory Committee
IM - Immunology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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