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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 K920198
Device Name GLYCOMAT HAEMOGLOBIN ANALYSER
Applicant
Drew Scientific , Ltd.
12 Barley Mow Passage
Chiswick
London W4 4ph Uk,  GB
Applicant Contact DREW
Correspondent
Drew Scientific , Ltd.
12 Barley Mow Passage
Chiswick
London W4 4ph Uk,  GB
Correspondent Contact DREW
Regulation Number864.7470
Classification Product Code
LCP  
Date Received01/15/1992
Decision Date 07/21/1992
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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