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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 K971919
Device Name EZCHEK/HBA BLOOD COLLECTION KIT
Applicant
Flexsite Diagnostics, Inc.
1900 K St. NW
Washington,  DC  20006 -1108
Applicant Contact DONALD R STONE
Correspondent
Flexsite Diagnostics, Inc.
1900 K St. NW
Washington,  DC  20006 -1108
Correspondent Contact DONALD R STONE
Regulation Number864.7470
Classification Product Code
LCP  
Date Received05/23/1997
Decision Date 09/05/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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