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FDA 510(k) Application Details - K002199
Device Classification Name
Hexokinase, Glucose
More FDA Info for this Device
510(K) Number
K002199
Device Name
Hexokinase, Glucose
Applicant
POINTE SCIENTIFIC, INC.
1025 JOHN A. PAPALAS DR.
LINCOLN PARK, MI 48146 US
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Contact
RON JAMISON
Other 510(k) Applications for this Contact
Regulation Number
862.1345
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Classification Product Code
CFR
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
07/20/2000
Decision Date
11/20/2000
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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