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FDA 510(k) Application Details - K961282
Device Classification Name
Hexokinase, Glucose
More FDA Info for this Device
510(K) Number
K961282
Device Name
Hexokinase, Glucose
Applicant
DIAGNOSTIC CHEMICALS LTD.
WEST ROYALTY INDUSTRIAL PARK,
CHARLOTTETOWN, P.E.I. C1E 2A6 CA
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Contact
KAREN CALLBECK
Other 510(k) Applications for this Contact
Regulation Number
862.1345
More FDA Info for this Regulation Number
Classification Product Code
CFR
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More FDA Info for this Product Code
Date Received
04/03/1996
Decision Date
06/21/1996
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CH - Clinical Chemistry
Review Advisory Committee
CH - Clinical Chemistry
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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