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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Control, Hemoglobin, Abnormal
510(k) Number K942222
Device Name QUIK-SEP QUANTITIVE HEMOGLOBIN S CONTROLS
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
JCM  
Date Received05/06/1994
Decision Date 01/20/1995
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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