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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 K081276
Device Name ABX PENTRA GLUCOSE HK CP, ABX PENTRA URIC ACID CP, ABX PENTRA URINE CONTROL L/H
Applicant
Horiba Abx
Parc Euromedecine
Rue Du Caducee Bp7290
Montpellier Cedex 4,  FR 34184
Applicant Contact OLIVIER DUCAMP
Correspondent
Horiba Abx
Parc Euromedecine
Rue Du Caducee Bp7290
Montpellier Cedex 4,  FR 34184
Correspondent Contact OLIVIER DUCAMP
Regulation Number862.1345
Classification Product Code
CFR  
Subsequent Product Codes
JJY   KNK  
Date Received05/05/2008
Decision Date 09/12/2008
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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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