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FDA 510(k) Application Details - K043543
Device Classification Name
System, Test, Blood Glucose, Over The Counter
More FDA Info for this Device
510(K) Number
K043543
Device Name
System, Test, Blood Glucose, Over The Counter
Applicant
AMERICAN HEALTHCARE INC.
304 PARK AVENUE SOUTH
SUITE 218
NEW YORK, NY 10010-4301 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
12/20/2004
Decision Date
04/08/2005
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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