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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name hexokinase, glucose
510(k) Number K062118
Device Name POINTE 360
Applicant
POINTE SCIENTIFIC, INC.
5449 RESEARCH DRIVE
CANTON,  MI  48188
Applicant Contact RON JAMISON
Correspondent
POINTE SCIENTIFIC, INC.
5449 RESEARCH DRIVE
CANTON,  MI  48188
Correspondent Contact RON JAMISON
Regulation Number862.1345
Classification Product Code
CFR  
Date Received07/25/2006
Decision Date 07/13/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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