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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Test, Qualitative And Quantitative Factor Deficiency
510(k) Number K050448
Device Name CHROMOPEP PC, CHROMOPEP AT, MODELS 2.5 AND 5
Applicant
Horiba Abx
Parc Euromedecine
Rue Du Caducee
Montpellier,  FR 34184
Applicant Contact TIM LAWTON
Correspondent
Horiba Abx
Parc Euromedecine
Rue Du Caducee
Montpellier,  FR 34184
Correspondent Contact TIM LAWTON
Regulation Number864.7290
Classification Product Code
GGP  
Subsequent Product Code
JBQ  
Date Received02/22/2005
Decision Date 09/23/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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