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FDA 510(k) Application Details - K143373
Device Classification Name
Single (Specified) Analyte Controls (Assayed And Unassayed)
More FDA Info for this Device
510(K) Number
K143373
Device Name
Single (Specified) Analyte Controls (Assayed And Unassayed)
Applicant
SIEMENS HEALTHCARE DIAGNOSTICS, INC.
5210 Pacific Concourse Drive
Los Angeles, CA 90045 US
Other 510(k) Applications for this Company
Contact
DONNA VELASQUEZ
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
11/25/2014
Decision Date
02/26/2015
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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