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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 K854717
Device Name NSI ASTRA TM TOTAL PROTEIN REAGENT KIT, NSI #7928
Applicant
NOBEL SCIENTIFIC INDUSTRIES, INC.
1423 LESLIE AVE.
ALEXANDRIA,  VA  22301
Applicant Contact DONALD F DWYER
Correspondent
NOBEL SCIENTIFIC INDUSTRIES, INC.
1423 LESLIE AVE.
ALEXANDRIA,  VA  22301
Correspondent Contact DONALD F DWYER
Regulation Number862.1635
Classification Product Code
CEK  
Date Received11/22/1985
Decision Date 01/14/1986
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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