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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name biuret (colorimetric), total protein
510(k) Number K870371
Device Name TOTAL PROTEIN REAGENT - BIURET 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 Number862.1635
Classification Product Code
CEK  
Date Received01/28/1987
Decision Date 08/19/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
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