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FDA 510(k) Application Details - K041230
Device Classification Name
Glucose Dehydrogenase, Glucose
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510(K) Number
K041230
Device Name
Glucose Dehydrogenase, Glucose
Applicant
HEMOCUE, INC.
9229 CRANFORD DR.
POTOMAC, MD 20854 US
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Contact
R.J. SLOMOFF
Other 510(k) Applications for this Contact
Regulation Number
862.1345
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Classification Product Code
LFR
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More FDA Info for this Product Code
Date Received
05/10/2004
Decision Date
05/20/2004
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CH - Clinical Chemistry
Review Advisory Committee
CH - Clinical Chemistry
Statement / Summary / Purged Status
Statement
Type
Special
Reviewed By Third Party
N
Expedited Review
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