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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Products, Red-Cell Lysing Products
510(k) Number K850944
Device Name NSI LYSING-D REAGENT -4000 ML
Applicant
NOBEL SCIENTIFIC INDUSTRIES, INC.
1423 LESLIE AVE.
ALEXANDRIA,  VA  22301
Applicant Contact DALE E THOMPSON
Correspondent
NOBEL SCIENTIFIC INDUSTRIES, INC.
1423 LESLIE AVE.
ALEXANDRIA,  VA  22301
Correspondent Contact DALE E THOMPSON
Regulation Number864.8540
Classification Product Code
GGK  
Date Received03/07/1985
Decision Date 03/29/1985
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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