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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Scissors, Ear
510(k) Number K914226
Device Name ACA(R) BETA-2-MICROGLOBULIN (B2M) TEST PACK
Applicant
E.I. Dupont DE Nemours & Co., Inc.
Du Pont-Bmp22/1152
Wilmington,  DE  19880
Applicant Contact CHRISTOPHER BENTSEN
Correspondent
E.I. Dupont DE Nemours & Co., Inc.
Du Pont-Bmp22/1152
Wilmington,  DE  19880
Correspondent Contact CHRISTOPHER BENTSEN
Regulation Number874.4420
Classification Product Code
JZB  
Date Received09/20/1991
Decision Date 11/19/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Immunology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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