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FDA 510(k) Application Details - K103612
Device Classification Name
Calibrator, Multi-Analyte Mixture
More FDA Info for this Device
510(K) Number
K103612
Device Name
Calibrator, Multi-Analyte Mixture
Applicant
SIEMENS HEALTHCARE DIAGNOSTICS INC
500 GBC DRIVE
P.O. BOX 6101
NEWARK, DE 19714-6101 US
Other 510(k) Applications for this Company
Contact
ANNA MARIE K ENNIS
Other 510(k) Applications for this Contact
Regulation Number
862.1150
More FDA Info for this Regulation Number
Classification Product Code
JIX
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
12/09/2010
Decision Date
01/25/2011
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
Expedited Review
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