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FDA 510(k) Application Details - K051651
Device Classification Name
System, Test, Blood Glucose, Over The Counter
More FDA Info for this Device
510(K) Number
K051651
Device Name
System, Test, Blood Glucose, Over The Counter
Applicant
U. S. DIAGNOSTICS, INC.
304 PARK AVENUE SOUTH
SUITE 218
NEW YORK, NY 10010 US
Other 510(k) Applications for this Company
Contact
EDWARD LETKO
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
06/21/2005
Decision Date
04/14/2006
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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