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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 K030553
Device Name ARKIT HBA1C
Applicant
Arkray, Inc.
2320 Scientific Park Dr.
Wilmington,  NC  28405
Applicant Contact GARY M HAIGHT
Correspondent
Arkray, Inc.
2320 Scientific Park Dr.
Wilmington,  NC  28405
Correspondent Contact GARY M HAIGHT
Regulation Number864.7470
Classification Product Code
LCP  
Subsequent Product Codes
JIT   JJX  
Date Received02/21/2003
Decision Date 09/02/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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