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FDA 510(k) Application Details - K032552
Device Classification Name
System, Test, Blood Glucose, Over The Counter
More FDA Info for this Device
510(K) Number
K032552
Device Name
System, Test, Blood Glucose, Over The Counter
Applicant
ROCHE DIAGNOSTICS CORP.
9115 HAGUE RD.
INDIANAPOLIS, IN 46250 US
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Contact
Scott Thiel
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Regulation Number
862.1345
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Classification Product Code
NBW
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More FDA Info for this Product Code
Date Received
08/19/2003
Decision Date
09/12/2003
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CH - Clinical Chemistry
Review Advisory Committee
CH - Clinical Chemistry
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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