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FDA 510(k) Application Details - K051034
Device Classification Name
Method, Enzymatic, Glucose (Urinary, Non-Quantitative)
More FDA Info for this Device
510(K) Number
K051034
Device Name
Method, Enzymatic, Glucose (Urinary, Non-Quantitative)
Applicant
MACHEREY-NAGEL GMBH & CO., KG.
7361 CALHOUN PLACE, SUITE 500
ROCKVILLE, MD 20855 US
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Contact
EDUARDO MARCH
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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
04/22/2005
Decision Date
11/22/2005
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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