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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 K880673
Device Name GHB SAMPLE PAPER
Applicant
Isolab, Inc.
Drawer 4350
Akron,  OH  44321
Applicant Contact WENDY S CLINE
Correspondent
Isolab, Inc.
Drawer 4350
Akron,  OH  44321
Correspondent Contact WENDY S CLINE
Regulation Number864.7470
Classification Product Code
LCP  
Date Received02/19/1988
Decision Date 11/22/1988
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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