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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Nephelometer
510(k) Number K001647
Device Name BN PROSPEC SYSTEM
Applicant
Dade Behring, Inc.
Glasgow Business Community;
Bldg. 500 Mail Box 514
P.O. Box 6101, Newark,  DE  19714
Applicant Contact REBECCA S AYASH
Correspondent
Dade Behring, Inc.
Glasgow Business Community;
Bldg. 500 Mail Box 514
P.O. Box 6101, Newark,  DE  19714
Correspondent Contact REBECCA S AYASH
Regulation Number866.4540
Classification Product Code
JZW  
Date Received05/30/2000
Decision Date 09/26/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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