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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 K041635
Device Name G5 I HBA1C TEST, G5 II HBA1C TEST
Applicant
Provalis Diagnostics , Ltd.
16809 Briardale Rd.
Rockville,  MD  20855
Applicant Contact THOMAS M TSAKERIS
Correspondent
Provalis Diagnostics , Ltd.
16809 Briardale Rd.
Rockville,  MD  20855
Correspondent Contact THOMAS M TSAKERIS
Regulation Number864.7470
Classification Product Code
LCP  
Subsequent Product Code
GGM  
Date Received06/16/2004
Decision Date 08/16/2004
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
Recalls CDRH Recalls
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