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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 K001392
Device Name GLYCOSAL HBA1C TEST
Applicant
PROVALIS DIAGNOSTICS LTD.
16809 BRIARDALE RD.
ROCKVILLE,  MD  20855
Applicant Contact TOM TSAKERIS
Correspondent
PROVALIS DIAGNOSTICS LTD.
16809 BRIARDALE RD.
ROCKVILLE,  MD  20855
Correspondent Contact TOM TSAKERIS
Regulation Number864.7470
Classification Product Code
LCP  
Date Received05/03/2000
Decision Date 08/21/2000
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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