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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Bromcresol Green Dye-Binding, Albumin
510(k) Number K854718
Device Name NSI ASTRA TM ALBUMIN REAGENT KIT NSI ITEM # 7926
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 Number862.1035
Classification Product Code
CIX  
Date Received11/22/1985
Decision Date 12/19/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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