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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 K862556
Device Name SANDARE GLYCOHEMOGLOBIN PROCEDURE
Applicant
Sandare Chemical Co., Inc.
P.O. Box 3028
Desoto,  TX  75115
Applicant Contact JAMES L SANDERS
Correspondent
Sandare Chemical Co., Inc.
P.O. Box 3028
Desoto,  TX  75115
Correspondent Contact JAMES L SANDERS
Regulation Number864.7470
Classification Product Code
LCP  
Date Received07/03/1986
Decision Date 08/08/1986
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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