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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Assay, Glycosylated Hemoglobin
510(k) Number K873428
Device Name GLYCO-PROBE GSP
Applicant
Isolab, Inc.
Drawer 4350
Akron,  OH  44321
Applicant Contact LOREN F HAZELWOOD
Correspondent
Isolab, Inc.
Drawer 4350
Akron,  OH  44321
Correspondent Contact LOREN F HAZELWOOD
Regulation Number864.7470
Classification Product Code
LCP  
Date Received08/25/1987
Decision Date 04/05/1988
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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