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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Abnormal Hemoglobin Quantitation
510(k) Number K050709
Device Name RESOLVE HEMOGLOBIN KIT, JB-2 STAINING SYSTEM, MODELS FR-9120, FR-9400, FR-9360, FR-9367
Applicant
Wallac OY
Mustionkatu 6
Turku,  FI 20750
Applicant Contact RAIJA KOSKIVAARA
Correspondent
Wallac OY
Mustionkatu 6
Turku,  FI 20750
Correspondent Contact RAIJA KOSKIVAARA
Regulation Number864.7415
Classification Product Code
GKA  
Date Received03/18/2005
Decision Date 03/08/2006
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
Recalls CDRH Recalls
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