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FDA 510(k) Application Details - K091216
Device Classification Name
Method, Enzymatic, Glucose (Urinary, Non-Quantitative)
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510(K) Number
K091216
Device Name
Method, Enzymatic, Glucose (Urinary, Non-Quantitative)
Applicant
SIEMENS HEALTHCARE DIAGNOSTICS
2 EDGEWATER DRIVE
NORWOOD, MA 02062 US
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Contact
NOOR MALKI
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Regulation Number
862.1340
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Classification Product Code
JIL
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More FDA Info for this Product Code
Date Received
04/27/2009
Decision Date
10/09/2009
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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