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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Calibrator, Secondary
510(k) Number K092570
Device Name ABX PENTRA TPU CAL, MODEL A11A01898
Applicant
HORIBA ABX SAS
Parc Euromedecine
Rue Du Caducee Bp7290
Montpellier,  FR 34184
Applicant Contact CAROLINE FERRER
Correspondent
HORIBA ABX SAS
Parc Euromedecine
Rue Du Caducee Bp7290
Montpellier,  FR 34184
Correspondent Contact CAROLINE FERRER
Regulation Number862.1150
Classification Product Code
JIT  
Date Received08/21/2009
Decision Date 10/16/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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