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FDA 510(k) Application Details - K062187
Device Classification Name
System, Test, Blood Glucose, Over The Counter
More FDA Info for this Device
510(K) Number
K062187
Device Name
System, Test, Blood Glucose, Over The Counter
Applicant
NATIONAL DIAGNOSTIC PRODUCTS
22/39 HERBERT STREET
ST. LEONARDS NSW 2065
SYDNEY AU
Other 510(k) Applications for this Company
Contact
BRANDON BRANSGROVE
Other 510(k) Applications for this Contact
Regulation Number
862.1345
More FDA Info for this Regulation Number
Classification Product Code
NBW
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
08/01/2006
Decision Date
03/24/2009
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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