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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Hemoglobin C (Abnormal Hemoglobin Variant)
510(k) Number K923153
Device Name HEMOCARD, HEMOGLOBIN C ASSAY
Applicant
Isolab, Inc.
Drawer 4350
Akron,  OH  44321
Applicant Contact JANET D PERKINS
Correspondent
Isolab, Inc.
Drawer 4350
Akron,  OH  44321
Correspondent Contact JANET D PERKINS
Regulation Number864.7415
Classification Product Code
MLL  
Date Received06/29/1992
Decision Date 01/27/1994
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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