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FDA 510(k) Application Details - K072413
Device Classification Name
System, Test, Blood Glucose, Over The Counter
More FDA Info for this Device
510(K) Number
K072413
Device Name
System, Test, Blood Glucose, Over The Counter
Applicant
AGAMATRIX
10 MAOR PARKWAY
SALEM, NH 03079 US
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Contact
CONNIE HERTEL
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
08/28/2007
Decision Date
09/27/2007
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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