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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 K002199
Device Name MODIFICATION TO LIQUID GLUCOSE (HEXOKINASE) REAGENT SET
Applicant
POINTE SCIENTIFIC, INC.
1025 JOHN A. PAPALAS DR.
LINCOLN PARK,  MI  48146
Applicant Contact RON JAMISON
Correspondent
POINTE SCIENTIFIC, INC.
1025 JOHN A. PAPALAS DR.
LINCOLN PARK,  MI  48146
Correspondent Contact RON JAMISON
Regulation Number862.1345
Classification Product Code
CFR  
Date Received07/20/2000
Decision Date 11/20/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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