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FDA 510(k) Application Details - K061528
Device Classification Name
Glucose Oxidase, Glucose
More FDA Info for this Device
510(K) Number
K061528
Device Name
Glucose Oxidase, Glucose
Applicant
CARD GUARD SCIENTIFIC SURVIVAL, LTD.
2 PEKERIS ST., SCIENCE PARK
P.O.B. 527
REHOVOT 76100 IL
Other 510(k) Applications for this Company
Contact
ALEX GONOROVSKY
Other 510(k) Applications for this Contact
Regulation Number
862.1345
More FDA Info for this Regulation Number
Classification Product Code
CGA
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
06/02/2006
Decision Date
09/22/2006
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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