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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Counter, Differential Cell
510(k) Number K090013
Device Name CHEMPAQ XBC ANALYZER
Applicant
Chempaq A/S
Hirsemarken 1b
Farum,  DK DK-3520
Applicant Contact LONE HOFFENSETS
Correspondent
Chempaq A/S
Hirsemarken 1b
Farum,  DK DK-3520
Correspondent Contact LONE HOFFENSETS
Regulation Number864.5220
Classification Product Code
GKZ  
Date Received01/02/2009
Decision Date 04/21/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Summary Summary
FDA Review Decision Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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