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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Assay, Bart'S, Hemoglobin
510(k) Number K810976
Device Name ALPHA-THAL SCREEN TM CONTROL
Applicant
Isolab, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Isolab, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number864.7500
Classification Product Code
LGL  
Date Received04/10/1981
Decision Date 05/29/1981
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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