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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 K811894
Device Name ORTHO SICKLE CELL CONTROLS
Applicant
Ortho Diagnostic Systems, Inc.
125 Mark Ave.
Carpinteria,  CA  93013
Correspondent
Ortho Diagnostic Systems, Inc.
125 Mark Ave.
Carpinteria,  CA  93013
Regulation Number864.7415
Classification Product Code
GKA  
Date Received07/01/1981
Decision Date 07/27/1981
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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