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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Whole Blood Hemoglobin Determination
510(k) Number K870363
Device Name HAEMOGLOBIN REAGENT - CYANMETHAEMOGLOBIN METHOD
Applicant
Trace Scientific , Ltd.
10 Treforest Dr.
Clayton, Vic 3168,  AU
Applicant Contact WILLIAM C RIDDLE
Correspondent
Trace Scientific , Ltd.
10 Treforest Dr.
Clayton, Vic 3168,  AU
Correspondent Contact WILLIAM C RIDDLE
Regulation Number864.7500
Classification Product Code
KHG  
Date Received01/28/1987
Decision Date 03/16/1987
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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