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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Hemoglobin A2 Quantitation
510(k) Number K924496
Device Name GLYCOMAT GREEN HBA2 ESTIMATION REAGENT KIT
Applicant
Drew Scientific , Ltd.
12 Barley Mow Passage
Chiswick
London W4 4ph Uk,  GB
Applicant Contact K. R DREW
Correspondent
Drew Scientific , Ltd.
12 Barley Mow Passage
Chiswick
London W4 4ph Uk,  GB
Correspondent Contact K. R DREW
Regulation Number864.7400
Classification Product Code
JPD  
Date Received09/04/1992
Decision Date 11/16/1992
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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