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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 K011933
Device Name GLYCOSAL II HBA 1C 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  
Date Received06/20/2001
Decision Date 11/02/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Clinical Chemistry
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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